Systems and methods allowing for reservoir filling and infusion medium delivery

ABSTRACT

A system includes a durable portion with a durable housing and a separable disposable portion with a disposable housing that selectively engage with and disengage from each other. The disposable housing secures to a patient and may be disposed of after it has been in use for a prescribed period. Components that normally come into contact with a patient or with an infusion medium may be part of the disposable portion to allow for disposal after a prescribed use. A reservoir for holding the infusion medium may be part of the disposable portion, and may be supported by the disposable housing. The durable portion may include other components such as electronics for controlling delivery of the infusion medium from the reservoir, and a drive device including a motor and drive linkage.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 11/588,875, filed Oct. 27, 2006, entitled “Systems and MethodsAllowing for Reservoir Filling and Infusion Medium Delivery”, thecontents of which are incorporated by reference herein.

Embodiments of the present invention relate to U.S. ProvisionalApplication Ser. No. 60/839,821, filed Aug. 23, 2006, entitled “Systemsand Methods Allowing for Reservoir Filling and Infusion MediumDelivery”, the contents of which are incorporated by reference hereinand which is a basis for a claim of priority.

Embodiments of the present invention relate to U.S. ProvisionalApplication Ser. No. 60/678,290, filed May 6, 2005, and to U.S. patentapplication Ser. No. 11/211,095, filed Aug. 23, 2005, each of which isincorporated by reference herein in its entirety.

Embodiments of the present invention relate to: (i) U.S. ProvisionalApplication Ser. No. 60/839,822, filed Aug. 23, 2006, entitled “InfusionMedium Delivery Device and Method with Drive Device for Driving Plungerin Reservoir”; (ii) U.S. Provisional Application Ser. No. 60/839,832,filed Aug. 23, 2006, entitled “Infusion Medium Delivery Device andMethod with Compressible or Curved Reservoir or Conduit”; (iii) U.S.Provisional Application Ser. No. 60/839,840, filed Aug. 23, 2006,entitled “Infusion Medium Delivery System, Device and Method with NeedleInserter and Needle Inserter Device and Method”; and (iv) U.S.Provisional Application Ser. No. 60/839,741, filed Aug. 23, 2006,entitled “Infusion Pumps and Methods and Delivery Devices and Methodswith Same”, the contents of each of which are incorporated by referenceherein, in their entirety.

Embodiments of the present invention also relate to: (i) U.S. patentapplication Ser. No. 11/588,832, filed Oct. 27, 2006, entitled “InfusionMedium Delivery Device and Method with Drive Device for Driving Plungerin Reservoir”; (ii) U.S. patent application Ser. No. 11/588,847, filedOct. 27, 2006, entitled “Infusion Medium Delivery Device and Method withCompressible or Curved Reservoir or Conduit”; (iii) U.S. ProvisionalPatent Application Ser. No. 60/854,829, filed Oct. 27, 2006, entitled“Infusion Medium Delivery System, Device and Method with Needle Inserterand Needle Inserter Device and Method”; and (iv) U.S. patent applicationSer. No. 11/589,323, filed Oct. 27, 2006, entitled “Infusion Pumps andMethods and Delivery Devices and Methods with Same”, the contents ofeach of which are incorporated by reference herein, in their entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

Embodiments of the present invention relate generally to structures,systems, and methods allowing for reservoir filling and, in specificembodiments, to an infusion medium delivery system allowing for fillinga reservoir with an infusion medium and for delivering the infusionmedium to a patient.

2. Related Art

According to modern medical techniques, certain chronic diseases may betreated by delivering a medication or other substance to the body of apatient. For example, diabetes is a chronic disease that is commonlytreated by delivering defined amounts of insulin to a patient atappropriate times. Traditionally, manually operated syringes and insulinpens have been employed for delivering insulin to a patient. Morerecently, modern systems have been designed to include programmablepumps for delivering controlled amounts of medication to a patient.However, some programmable pump delivery systems operate for only aprescribed period of time and require disposal when one or more systemcomponents have exceeded an operational lifetime, even if other systemcomponents are still operational.

Pump type delivery devices have been configured in external devices,which connect to a patient, and have also been configured in implantabledevices, which are implanted inside of the body of a patient. Externalpump type delivery devices include devices designed for use in astationary location, such as a hospital, a clinic, or the like, andfurther include devices configured for ambulatory or portable use, suchas devices that are designed to be carried by a patient, or the like.External pump type delivery devices may be connected in fluid flowcommunication to a patient or user, for example, through a suitablehollow tubing. The hollow tubing may be connected to a hollow needlethat is designed to pierce the skin of the patient and to deliver aninfusion medium there-through. Alternatively, the hollow tubing may beconnected directly to the patient as or through a cannula, or the like.

Examples of some external pump type delivery devices are described inthe following references: (i) Published PCT Application WO 01/70307(PCT/US01/09139), entitled “Exchangeable Electronic Cards for InfusionDevices”; (ii) Published PCT Application WO 04/030716(PCT/US2003/028769), entitled “Components and Methods for PatientInfusion Device”; (iii) Published PCT Application WO 04/030717(PCT/US2003/029019), entitled “Dispenser Components and Methods forInfusion Device”; (iv) U.S. Patent Application Pub. No. 2005/0065760,entitled “Method for Advising Patients Concerning Doses Of Insulin”; and

(v) U.S. Pat. No. 6,589,229, entitled “Wearable Self-Contained DrugInfusion Device”, each of which is incorporated by reference herein inits entirety.

As compared to syringes and insulin pens, pump type delivery devices canbe significantly more convenient to a patient, in that accurate doses ofinsulin may be calculated and delivered automatically to a patient atany time during the day or night. Furthermore, when used in conjunctionwith glucose sensors or monitors, insulin pumps may be automaticallycontrolled to provide appropriate doses of an infusion medium atappropriate times of need, based on sensed or monitored levels of bloodglucose. As a result, pump type delivery devices have become animportant aspect of modern medical treatments of various types ofmedical conditions, such as diabetes, and the like. As pump technologiesimprove and doctors and patients become more familiar with such devices,external medical infusion pump treatments are expected to increase inpopularity and are expected to increase substantially in number over thenext decade.

SUMMARY OF THE DISCLOSURE

Embodiments of the present invention relate to systems and methods thatallow for reservoir filling. Some embodiments of the present inventionallow for delivering an infusion medium from a reservoir to the body ofa patient.

A system in accordance with an embodiment of the present inventionincludes a reservoir, a piston, a plunger shaft, and a handle. Thereservoir allows for holding an infusion medium. The piston is disposedat least partially within the reservoir, and the piston is moveable toallow the infusion medium to fill into the reservoir and to force theinfusion medium out of the reservoir. The plunger shaft is connected tothe piston. The plunger shaft has a mating portion for mating with alinkage portion of a drive device, where the drive device allows fordriving the plunger shaft so as to move the piston to force the infusionmedium out of the reservoir when the linkage portion of the drive deviceis mated with the mating portion of the plunger shaft. The handle has ahandle mating portion for mating with the mating portion of the plungershaft. The handle is capable of being used by a user to move the plungershaft so as to move the piston to allow the infusion medium to fill intothe reservoir when the handle mating portion of the handle is mated withthe mating portion of the plunger shaft.

In various embodiments, the mating portion of the plunger shaft isthreaded. Also, in various embodiments, the handle mating portion of thehandle is threaded. In some embodiments, the mating portion of theplunger shaft includes a partial nut, and the handle mating portion ofthe handle includes a threaded interface. Also, in some embodiments, thehandle has a gripping arm for gripping the plunger shaft when the handlemating portion of the handle is mated with the mating portion of theplunger shaft.

In various embodiments, the reservoir has a port that is connectable toan infusion path to allow for delivering the infusion medium from thereservoir to the body of a particular user. In further embodiments, theport is connectable to a transfer path to allow for the infusion mediumto be filled into the reservoir from an infusion medium container. Invarious embodiments, the system further includes a transfer guard thatis connectable to the reservoir for providing a path to allow theinfusion medium to be transferred from an infusion medium container tothe reservoir.

In some embodiments, the system further includes a base adapted to besecured to a particular user, and the reservoir is connected to thebase. In further embodiments, the reservoir is connectable to aninfusion path to allow for delivering the infusion medium from thereservoir to the body of the particular user through an opening in thebase. Also, in some embodiments, the system further includes the drivedevice having the linkage portion, where the drive device furtherincludes a motor for moving the linkage portion, and where the motor isable to move the linkage portion of the drive device so as to drive theplunger shaft when the linkage portion of the drive device is mated withthe mating portion of the plunger shaft.

In various embodiments, the linkage portion of the drive device isthreaded. Also, in various embodiments, the system includes a disposablehousing for housing the reservoir and for being secured to a particularuser, and a durable housing for housing the motor of the drive device,where the durable housing is configured to be selectively engaged withand disengaged from the disposable housing. In some embodiments, thereservoir has a degassing portion that includes a hydrophobic materialfor allowing gases to escape from the reservoir while keeping theinfusion medium within the reservoir. Also, in some embodiments, thepiston has a degassing portion that includes a hydrophobic material forallowing gases to escape from the reservoir while keeping the infusionmedium within the reservoir. In various embodiments, the system mayinclude a particular degassing portion that is located anywhere in afluid line. Also, in various embodiments, the system may include ahydrophobic material that is able to be sealed after it has been usedfor degassing.

A system in accordance with another embodiment of the present inventionincludes a reservoir and a piston. The reservoir allows for holding aninfusion medium. The piston is disposed at least partially within thereservoir, and the piston is moveable within the reservoir. The pistonincludes a piston body and a piston septum. The piston body allows forforcing the infusion medium out of the reservoir, and the piston body isconfigured to have an opening. The piston septum is capable of beingpierced to allow the infusion medium to be filled into the reservoirthrough the opening in the piston body.

In various embodiments, the piston is moveable to allow the infusionmedium to be filled into the reservoir. Also, in various embodiments,the reservoir has an outlet port that is connectable to an infusion pathto allow for delivering the infusion medium from the reservoir to thebody of a user. In some embodiments, the piston septum is located withinthe opening in the piston body. Also, in some embodiments, the pistonseptum covers the opening in the piston body. In various embodiments,the piston septum is a self sealing septum so as to allow for keepingthe infusion medium within the reservoir when the piston septum is notbeing pierced.

In some embodiments, the system further includes a fill apparatus. Invarious embodiments, the fill apparatus includes an engagement portion,a compressible portion, and a needle. In some embodiments, theengagement portion of the fill apparatus is able to engage with anengagement portion of the piston body. In various embodiments, thecompressible portion is able to be compressed. Also, in variousembodiments, the needle allows for piercing the piston septum when theengagement portion of the fill apparatus is engaged with the engagementportion of the piston body and the compressible portion of the fillapparatus is compressed. In some embodiments, the needle provides a pathfor transferring the infusion medium from an infusion medium containerto the reservoir when the needle has pierced the piston septum.

In further embodiments, the fill apparatus includes a covering portionfor at least partially surrounding a first end of the needle that isopposite a second end of the needle, where the second end of the needleis capable of piercing the piston septum when the engagement portion ofthe fill apparatus is engaged with the engagement portion of the pistonbody and the compressible portion of the fill apparatus is compressed.Also, in further embodiments, the piston is configured such that whenthe engagement portion of the fill apparatus is engaged with theengagement portion of the piston body and a user pulls on the fillapparatus, the piston moves within the reservoir so as to allow theinfusion medium to be filled into the reservoir.

In some embodiments, the engagement portion of the fill apparatus isthreaded, and the engagement portion of the piston body is threaded. Invarious embodiments, the compressible portion of the fill apparatusincludes a bellows. Also, in various embodiments, the system furtherincludes a plunger shaft having an engagement portion for engaging withthe engagement portion of the piston body and having a mating portionfor mating with a linkage portion of a drive device, where the drivedevice allowing for driving the plunger shaft so as to move the pistonbody to force the infusion medium out of the reservoir when the linkageportion of the drive device is mated with the mating portion of theplunger shaft.

In some embodiments, the system further includes the drive device havingthe linkage portion, where the drive device further includes a motor formoving the linkage portion. Also, in some embodiments, the systemfurther includes a disposable housing for housing the reservoir and forbeing secured to a user, and a durable housing for housing the motor ofthe drive device, where the durable housing is configured to beselectively engaged with and disengaged from the disposable housing. Invarious embodiments, the reservoir has a degassing portion that includesa hydrophobic material for allowing gases to escape from the reservoirwhile keeping the infusion medium within the reservoir. Also, in variousembodiments, the piston has a degassing portion that includes ahydrophobic material for allowing gases to escape from the reservoirwhile keeping the infusion medium within the reservoir.

A system in accordance with yet another embodiment of the presentinvention includes an infusion medium container, a plunger, a reservoir,and a transfer guard. The infusion medium container allows for holdingan infusion medium. The plunger is disposed at least partially withinthe infusion medium container, and the plunger is moveable within theinfusion medium container. The plunger includes a plunger body and aplunger septum. The plunger body allows for forcing the infusion mediumout of the infusion medium container, and the plunger body is configuredto have an opening. The plunger septum is capable of being pierced toallow the infusion medium to flow out of the infusion medium containerthrough the opening in the plunger body. The reservoir allows forholding the infusion medium, and the reservoir has a port for receivingthe infusion medium. The transfer guard has a transfer element forpiercing the plunger septum and for providing a path to allow theinfusion medium to be transferred from the infusion medium container tothe reservoir.

In various embodiments, the infusion medium container includes a vial.Also, in various embodiments, the transfer element includes a needle. Insome embodiments, the transfer guard has a first guard portion that iscapable of at least partially surrounding a first end of the needle, andthe transfer guard has a second guard portion that is capable of atleast partially surrounding a second end of the needle. In variousembodiments, the plunger septum is a self sealing septum that is able toseal after being pierced.

In some embodiments, the port of the reservoir is connectable to aninfusion path to allow for delivering the infusion medium from thereservoir to the body of a user. Also, in some embodiments, thereservoir has a degassing portion that includes a hydrophobic materialfor allowing gases to escape from the reservoir while keeping theinfusion medium within the reservoir. In various embodiments, the systemfurther includes a piston disposed at least partially within thereservoir, where the piston is moveable to allow the infusion medium tofill into the reservoir and to force the infusion medium out of thereservoir. In further embodiments, the piston has a degassing portionthat includes a hydrophobic material for allowing gases to escape fromthe reservoir while keeping the infusion medium within the reservoir.

In various embodiments, the system further includes a plunger shaftconnected to the piston, where the plunger shaft has a mating portionfor mating with a linkage portion of a drive device, and the drivedevice allows for driving the plunger shaft so as to move the piston toforce the infusion medium out of the reservoir when the linkage portionof the drive device is mated with the mating portion of the plungershaft. Also, in various embodiments, the system further includes thedrive device having the linkage portion, where the drive device furtherincludes a motor for moving the linkage portion. In some embodiments,the system further includes a disposable housing for housing thereservoir and for being secured to a user, and a durable housing forhousing the motor of the drive device, where the durable housing isconfigured to be selectively engaged with and disengaged from thedisposable housing.

A system in accordance with yet another embodiment of the presentinvention includes a reservoir. The reservoir allows for receiving aninfusion medium from an infusion medium container. The reservoirincludes a collapsible housing. The collapsible housing has an interiorvolume for holding the infusion medium. The collapsible housing iscollapsible from an expanded state to reduce the interior volume and isexpandable from a collapsed state to increase the interior volume. Thecollapsible housing is biased toward the expanded state. Also, thecollapsible housing is configured such that upon the collapsible housingbeing expanded toward the expanded state, a pressure differential iscreated between the interior volume of the collapsible housing and theinfusion medium container sufficient to transfer the infusion mediumfrom the infusion medium container to the interior volume of thecollapsible housing.

In various embodiments, the collapsible housing includes a bellows. Insome embodiments, the collapsible housing includes a metal. Also, insome embodiments, the collapsible housing includes at least one oftitanium, stainless steel, plastic, rubber, and TOPAS™. In variousembodiments, the collapsible housing includes a bias member for biasingthe collapsible housing toward the expanded state. In furtherembodiments, the bias member includes a spring.

In some embodiments, the system further includes a base adapted to besecured to a user, a durable housing portion configured to beselectively engaged with and disengaged from the base, and electroniccircuitry contained in the durable housing portion. Also, in someembodiments, the reservoir is supported by the base, and the electroniccircuitry is configured to control a delivery of the infusion mediumfrom the reservoir to the body of the user when the durable housingportion and the base are engaged. In various embodiments, the systemfurther includes a lever that is moveable among a plurality of positionsincluding a first position and a second position, where the lever isable to keep the collapsible housing in the collapsed state when thecollapsible housing is in the collapsed state and the lever is in thefirst position, and where the collapsible housing is able to expand tothe expanded state when the lever is in the second position. In variousembodiments, the lever is moveable to multiple positions along anexpansion direction of the collapsible housing.

In some embodiments, the reservoir further includes a port in fluid flowcommunication with the interior volume of the collapsible housing, andthe port is connectable to the infusion medium container. Also, in someembodiments, the system further includes a peristaltic pump fortransferring the infusion medium from the collapsible housing to thebody of a user. In various embodiments, the system further includes abase adapted to be secured to the user, and a durable housing portionconfigured to be selectively engaged with and disengaged from the base,where the reservoir is supported by the base, and where the peristalticpump is contained in the durable housing portion.

A system in accordance with yet another embodiment of the presentinvention includes a reservoir. The reservoir allows for receiving aninfusion medium from an infusion medium container, where the infusionmedium container has an interior volume for holding the infusion medium.The reservoir includes a collapsible housing and a chamber housing. Thecollapsible housing has an interior volume for holding the infusionmedium. The collapsible housing is collapsible from an expanded state toreduce the interior volume of the collapsible housing and is expandablefrom a collapsed state to increase the interior volume of thecollapsible housing. The chamber housing has an interior volume borderedon at least one side by the collapsible housing such that the interiorvolume of the chamber housing increases as the collapsible housingcollapses toward the collapsed state and such that the interior volumeof the chamber housing decreases as the collapsible housing expandstoward the expanded state.

In various embodiments, the collapsible housing and the chamber housingare configured such that when a gaseous pressure within the interiorvolume of the chamber housing is less than a particular gaseous pressurewithin the interior volume of the infusion medium container and thecollapsible housing is in the collapsed state and a path fortransferring the infusion medium is established between the interiorvolume of the infusion medium container and the interior volume of thecollapsible housing, the collapsible housing and the chamber housingallow for a pressure differential between the interior volume of thechamber housing and the interior volume of the infusion medium containerto cause the collapsible housing to expand and to cause the infusionmedium to be pushed from the infusion medium container to thecollapsible housing.

In some embodiments, the collapsible housing includes a bellows. Also,in some embodiments, the collapsible housing includes plastic, or thelike. In various embodiments, the system further includes a base adaptedto be secured to a user, a durable housing portion configured to beselectively engaged with and disengaged from the base, and electroniccircuitry contained in the durable housing portion, where the reservoiris supported by the base, and where the electronic circuitry isconfigured to control a delivery of the infusion medium from thereservoir to the body of the user when the durable housing portion andthe base are engaged.

In various embodiments, the reservoir further includes a port in fluidflow communication with the interior volume of the collapsible housing,and the port is connectable to the infusion medium container. In someembodiments, the system further includes a peristaltic pump fortransferring the infusion medium from the collapsible housing to thebody of a user. Also, in some embodiments, the system further includes abase adapted to be secured to the user, and a durable housing portionconfigured to be selectively engaged with and disengaged from the base,where the reservoir is supported by the base, and where the peristalticpump is contained in the durable housing.

Therefore, embodiments of the present invention relate to systems thatallow for reservoir filling. Such systems may allow for separatingdisposable components from durable components, so that the disposablecomponents can be disposed of separate from the durable components.Various other embodiments relate to methods of making and using suchsystems for reservoir filling.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a generalized representation of an infusion mediumdelivery system in accordance with an embodiment of the presentinvention;

FIG. 2 illustrates an example of an infusion medium delivery system inaccordance with an embodiment of the present invention;

FIG. 3 illustrates an example of a delivery device in accordance with anembodiment of the present invention;

FIG. 4 illustrates a view of a delivery device in accordance with anembodiment of the present invention;

FIG. 5A illustrates a durable portion of a delivery device in accordancewith an embodiment of the present invention;

FIG. 5B illustrates a section view of a durable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 5C illustrates a section view of a durable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 6A illustrates a disposable portion of a delivery device inaccordance with an embodiment of the present invention;

FIG. 6B illustrates a section view of a disposable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 6C illustrates a section view of a disposable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 7 illustrates a block diagram of a system in accordance with anembodiment of the present invention;

FIG. 8 illustrates a portion of an embodiment of a system in accordancewith an embodiment of the present invention;

FIG. 9 illustrates a portion of an embodiment of a system in accordancewith another embodiment of the present invention;

FIG. 10 illustrates another portion of an embodiment of a system inaccordance with an embodiment of the present invention;

FIG. 11 illustrates a portion of an embodiment of a system in accordancewith an embodiment of the present invention;

FIG. 12 illustrates another portion of an embodiment of a system inaccordance with an embodiment of the present invention;

FIG. 13 illustrates a portion of an embodiment of a system in accordancewith an embodiment of the present invention;

FIG. 14 illustrates a flow chart of a method of using an embodiment of asystem in accordance with an embodiment of the present invention;

FIG. 15 illustrates a block diagram of a system in accordance with anembodiment of the present invention;

FIG. 16 illustrates a portion of an embodiment of a system in accordancewith an embodiment of the present invention;

FIG. 17 illustrates another portion of an embodiment of a system inaccordance with an embodiment of the present invention;

FIG. 18 illustrates the portion of an embodiment of the system inaccordance with an embodiment of the present invention;

FIG. 19 illustrates a flow chart of a method of using an embodiment of asystem in accordance with an embodiment of the present invention;

FIG. 20 illustrates a block diagram of a system in accordance with anembodiment of the present invention;

FIG. 21 illustrates a portion of an embodiment of a system in accordancewith an embodiment of the present invention;

FIG. 22 illustrates a flow chart of a method of using an embodiment of asystem in accordance with an embodiment of the present invention;

FIG. 23 illustrates a block diagram of a system in accordance with anembodiment of the present invention;

FIG. 24 illustrates an embodiment of a system in accordance with anembodiment of the present invention;

FIG. 25 illustrates an embodiment of a system in accordance with anembodiment of the present invention;

FIG. 26 illustrates an embodiment of a system in accordance with anembodiment of the present invention;

FIG. 27 illustrates a block diagram of a system in accordance with anembodiment of the present invention;

FIG. 28 illustrates an embodiment of a system in accordance with anembodiment of the present invention;

FIG. 29 illustrates an embodiment of a system in accordance with anembodiment of the present invention; and

FIG. 30 illustrates an embodiment of a handle in accordance with anembodiment of the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

FIG. 1 illustrates a generalized representation of an infusion mediumdelivery system 10 in accordance with an embodiment of the presentinvention. The infusion medium delivery system 10 includes a deliverydevice 12. The infusion medium delivery system 10 may further include asensing device 14, a command control device (CCD) 16, and a computer 18.In various embodiments, the delivery device 12 and the sensing device 14may be secured at desired locations on the body 5 of a patient or user7. The locations at which the delivery device 12 and the sensing device14 are secured to the body 5 of the user 7 in FIG. 1 are provided onlyas representative, non-limiting, examples.

The delivery device 12 is configured to deliver an infusion medium tothe body 5 of the user 7. In various embodiments, the infusion mediumincludes a liquid, a fluid, a gel, or the like. In some embodiments, theinfusion medium includes a medicine or a drug for treating a disease ora medical condition. For example, the infusion medium may includeinsulin for treating diabetes, or may include a drug for treating pain,cancer, a pulmonary disorder, HIV, or the like. In some embodiments, theinfusion medium includes a nutritional supplement, a dye, a tracingmedium, a saline medium, a hydration medium, or the like.

The sensing device 14 includes a sensor, a monitor, or the like, forproviding sensor data or monitor data. In various embodiments, thesensing device 14 may be configured to sense a condition of the user 7.For example, the sensing device 14 may include electronics and enzymesreactive to a biological condition, such as a blood glucose level, orthe like, of the user 7. In various embodiments, the sensing device 14may be secured to the body 5 of the user 7 or embedded in the body 5 ofthe user 7 at a location that is remote from the location at which thedelivery device 12 is secured to the body 5 of the user 7. In variousother embodiments, the sensing device 14 may be incorporated within thedelivery device 12.

Each of the delivery device 12, the sensing device 14, the CCD 16, andthe computer 18 may include transmitter, receiver, or transceiverelectronics that allow for communication with other components of theinfusion medium delivery system 10. The sensing device 14 may beconfigured to transmit sensor data or monitor data to the deliverydevice 12. The sensing device 14 may also be configured to communicatewith the CCD 16. The delivery device 12 may include electronics andsoftware that are configured to analyze sensor data and to deliver theinfusion medium to the body 5 of the user 7 based on the sensor dataand/or preprogrammed delivery routines.

The CCD 16 and the computer 18 may include electronics and othercomponents configured to perform processing, delivery routine storage,and to control the delivery device 12. By including control functions inthe CCD 16 and/or the computer 18, the delivery device 12 may be madewith more simplified electronics. However, in some embodiments, thedelivery device 12 may include all control functions, and may operatewithout the CCD 16 and the computer 18. In various embodiments, the CCD16 may be a portable electronic device. Also, in various embodiments,the delivery device 12 and/or the sensing device 14 may be configured totransmit data to the CCD 16 and/or the computer 18 for display orprocessing of the data by the CCD 16 and/or the computer 18. Examples ofthe types of communications and/or control capabilities, as well asdevice feature sets and/or program options may be found in U.S. patentapplication Ser. No. 10/445,477 filed May 27, 2003, and entitled“External Infusion Device with Remote Programming, Bolus Estimatorand/or Vibration Alarm Capabilities,” and U.S. patent application Ser.No. 10/429,385 filed May 5, 2003, and entitled “Handheld Personal DataAssistant (PDA) with a Medical Device and Method of Using the Same,”U.S. patent application Ser. No. 09/813,660 filed Mar. 21, 2001, andentitled “Control Tabs For Infusion Devices And Methods Of Using TheSame,” all of which are incorporated herein by reference in theirentirety.

FIG. 2 illustrates an example of the infusion medium delivery system 10in accordance with an embodiment of the present invention. The infusionmedium delivery system 10 in accordance with the embodiment illustratedin FIG. 2 includes the delivery device 12 and the sensing device 14. Thedelivery device 12 in accordance with an embodiment of the presentinvention includes a disposable housing 20, a durable housing 30, and areservoir 40. The delivery device 12 may further include an infusionpath 50.

Elements of the delivery device 12 that ordinarily contact the body of auser or that ordinarily contact an infusion medium during operation ofthe delivery device 12 may be considered as a disposable portion of thedelivery device 12. For example, a disposable portion of the deliverydevice 12 may include the disposable housing 20 and the reservoir 40.The disposable portion of the delivery device 12 may be recommended fordisposal after a specified number of uses.

On the other hand, elements of the delivery device 12 that do notordinarily contact the body of the user or the infusion medium duringoperation of the delivery device 12 may be considered as a durableportion of the delivery device 12. For example, a durable portion of thedelivery device 12 may include the durable housing 30, electronics (notshown in FIG. 2), a drive device having a motor and drive linkage (notshown in FIG. 2), and the like. Elements of the durable housing portionof the delivery device 12 are typically not contaminated from contactwith the user or the infusion medium during normal operation of thedelivery device 12 and, thus, may be retained for re-use with replaceddisposable portions of the delivery device 12.

In various embodiments, the disposable housing 20 supports the reservoir40 and has a bottom surface (facing downward and into the page in FIG.2) that is configured to secure to the body of a user. An adhesive maybe employed at an interface between the bottom surface of the disposablehousing 20 and the skin of a user, so as to adhere the disposablehousing 20 to the skin of the user. In various embodiments, the adhesivemay be provided on the bottom surface of the disposable housing 20, witha peelable cover layer covering the adhesive material. In this manner,the cover layer may be peeled off to expose the adhesive material, andthe adhesive side of the disposable housing 20 may be placed against theskin of the user.

The reservoir 40 is configured for containing or holding an infusionmedium, such as, but not limited to insulin. In various embodiments, thereservoir 40 includes a hollow interior volume for receiving theinfusion medium, such as, but not limited to, a cylinder-shaped volume,a tubular-shaped volume, or the like. In some embodiments, the reservoir40 may be provided as a cartridge or canister for containing an infusionmedium. In various embodiments, the reservoir 40 is able to be refilledwith an infusion medium.

The reservoir 40 may be supported by the disposable housing 20 in anysuitable manner. For example, the disposable housing 20 may be providedwith projections or struts (not shown), or a trough feature (not shown),for holding the reservoir 40. In some embodiments, the reservoir 40 maybe supported by the disposable housing 20 in a manner that allows thereservoir 40 to be removed from the disposable housing 20 and replacedwith another reservoir. Alternatively, or in addition, the reservoir 40may be secured to the disposable housing 20 by a suitable adhesive, astrap, or other coupling structure.

In various embodiments, the reservoir 40 includes a port 41 for allowingan infusion medium to flow into and/or flow out of the interior volumeof the reservoir 40. In some embodiments, the infusion path 50 includesa connector 56, a tube 54, and a needle apparatus 52. The connector 56of the infusion path 50 may be connectable to the port 41 of thereservoir 40. In various embodiments, the disposable housing 20 isconfigured with an opening near the port 41 of the reservoir 40 forallowing the connector 56 of the infusion path 50 to be selectivelyconnected to and disconnected from the port 41 of the reservoir 40.

In various embodiments, the port 41 of the reservoir 40 is covered withor supports a septum (not shown in FIG. 2), such as a self-sealingseptum, or the like. The septum may be configured to prevent an infusionmedium from flowing out of the reservoir 40 through the port 41 when theseptum is not pierced. Also, in various embodiments, the connector 56 ofthe infusion path 50 includes a needle for piercing the septum coveringthe port 41 of the reservoir 40 so as to allow the infusion medium toflow out of the interior volume of the reservoir 40. Examples ofneedle/septum connectors can be found in U.S. patent application Ser.No. 10/328,393 filed Dec. 22, 2003, and entitled “Reservoir Connector,”which is incorporated herein by reference in its entirety. In otheralternatives, non-septum connectors such as Luer locks, or the like maybe used. In various embodiments, the needle apparatus 52 of the infusionpath 50 includes a needle that is able to puncture skin of a user. Also,in various embodiments, the tube 54 connects the connector 56 with theneedle apparatus 52 and is hollow, such that the infusion path 50 isable to provide a path to allow for the delivery of an infusion mediumfrom the reservoir 40 to the body of a user.

The durable housing 30 of the delivery device 12 in accordance withvarious embodiments of the present invention includes a housing shellconfigured to mate with and secure to the disposable housing 20. Thedurable housing 30 and the disposable housing 20 may be provided withcorrespondingly shaped grooves, notches, tabs, or other suitablefeatures, that allow the two parts to easily connect together, bymanually pressing the two housings together, by twist or threadedconnection, or other suitable manner of connecting the parts that iswell known in the mechanical arts. In various embodiments, the durablehousing 30 and the disposable housing 20 may be connected to each otherusing a twist action. The durable housing 30 and the disposable housing20 may be configured to be separable from each other when a sufficientforce is applied to disconnect the two housings from each other. Forexample, in some embodiments the disposable housing 20 and the durablehousing 30 may be snapped together by friction fitting. In variousembodiments, a suitable seal, such as an o-ring seal, may be placedalong a peripheral edge of the durable housing 30 and/or the disposablehousing 20, so as to provide a seal against water entering between thedurable housing 30 and the disposable housing 20.

The durable housing 30 of the delivery device 12 may support a drivedevice (not shown in FIG. 2), including a motor and a drive devicelinkage portion, for applying a force to the infusion medium within thereservoir 40 to force the infusion medium out of the reservoir 40 andinto an infusion path, such as the infusion path 50, for delivery to auser. For example, in some embodiments, an electrically driven motor maybe mounted within the durable housing 30 with appropriate linkage foroperatively coupling the motor to a plunger shaft (not shown in FIG. 2)connected to a piston (not shown in FIG. 2) that is within the reservoir40 and to drive the piston in a direction to force the infusion mediumout of the port 41 of the reservoir 40 and to the user. Also, in someembodiments, the motor may be controllable to reverse direction so as tomove the plunger shaft and the piston to cause fluid to be drawn intothe reservoir 40 from a patient. The motor may be arranged within thedurable housing 30 and the reservoir 40 may be correspondingly arrangedon the disposable housing 20, such that the operable engagement of themotor with the piston, through the appropriate linkage, occursautomatically upon the user connecting the durable housing 30 with thedisposable housing 20 of the delivery device 12. Further examples oflinkage and control structures may be found in U.S. patent applicationSer. No. 09/813,660 filed Mar. 21, 2001, and entitled “Control Tabs ForInfusion Devices And Methods Of Using The Same,” which is incorporatedherein by reference in its entirety.

In various embodiments, the durable housing 30 and the disposablehousing 20 may be made of suitably rigid materials that maintain theirshape, yet provide sufficient flexibility and resilience to effectivelyconnect together and disconnect, as described above. The material of thedisposable housing 20 may be selected for suitable compatibility withskin. For example, the disposable housing 20 and the durable housing 30of the delivery device 12 may be made of any suitable plastic, metal,composite material, or the like. The disposable housing 20 may be madeof the same type of material or a different material relative to thedurable housing 30. In some embodiments, the disposable housing 20 andthe durable housing 30 may be manufactured by injection molding or othermolding processes, machining processes, or combinations thereof.

For example, the disposable housing 20 may be made of a relativelyflexible material, such as a flexible silicone, plastic, rubber,synthetic rubber, or the like. By forming the disposable housing 20 of amaterial capable of flexing with the skin of a user, a greater level ofuser comfort may be achieved when the disposable housing 20 is securedto the skin of the user. Also, a flexible disposable housing 20 mayresult in an increase in site options on the body of the user at whichthe disposable housing 20 may be secured.

In the embodiment illustrated in FIG. 2, the delivery device 12 isconnected to the sensing device 14 through a connection element 16 ofthe sensing device 14. The sensing device 14 may include a sensor 15that includes any suitable biological or environmental sensing device,depending upon a nature of a treatment to be administered by thedelivery device 12. For example, in the context of delivering insulin toa diabetes patient, the sensor 15 may include a blood glucose sensor, orthe like.

The sensor 15 may be an external sensor that secures to the skin of auser or, in other embodiments, may be an implantable sensor that islocated in an implant site within the body of the user. In furtheralternatives, the sensor may be included with as a part or along sidethe infusion cannula and/or needle, such as for example as shown in U.S.patent Ser. No. 11/149,119 filed Jun. 8, 2005, and entitled “DualInsertion Set,” which is incorporated herein by reference in itsentirety. In the illustrated example of FIG. 2, the sensor 15 is anexternal sensor having a disposable needle pad that includes a needlefor piercing the skin of the user and enzymes and/or electronicsreactive to a biological condition, such as blood glucose level or thelike, of the user. In this manner, the delivery device 12 may beprovided with sensor data from the sensor 15 secured to the user at asite remote from the location at which the delivery device 12 is securedto the user.

While the embodiment shown in FIG. 2 includes a sensor 15 connected bythe connection element 16 for providing sensor data to sensorelectronics (not shown in FIG. 2) located within the durable housing 30of the delivery device 12, other embodiments may employ a sensor 15located within the delivery device 12. Yet other embodiments may employa sensor 15 having a transmitter for communicating sensor data by awireless communication link with receiver electronics (not shown in FIG.2) located within the durable housing 30 of the delivery device 12. Invarious embodiments, a wireless connection between the sensor 15 and thereceiver electronics within the durable housing 30 of the deliverydevice 12 may include a radio frequency (RF) connection, an opticalconnection, or another suitable wireless communication link. Furtherembodiments need not employ the sensing device 14 and, instead, mayprovide infusion medium delivery functions without the use of sensordata.

As described above, by separating disposable elements of the deliverydevice 12 from durable elements, the disposable elements may be arrangedon the disposable housing 20, while durable elements may be arrangedwithin a separable durable housing 30. In this regard, after aprescribed number of uses of the delivery device 12, the disposablehousing 20 may be separated from the durable housing 30, so that thedisposable housing 20 may be disposed of in a proper manner. The durablehousing 30 may then be mated with a new (un-used) disposable housing 20for further delivery operation with a user.

FIG. 3 illustrates an example of the delivery device 12 in accordancewith another embodiment of the present invention. The delivery device 12of the embodiment of FIG. 3 is similar to the delivery device 12 of theembodiment of FIG. 2. While the delivery device 12 in the embodimentillustrated in FIG. 2 provides for the durable housing 30 to cover thereservoir 40, the delivery device 12 in the embodiment of FIG. 3provides for the durable housing 30 to secure to the disposable housing20 without covering the reservoir 40. The delivery device 12 of theembodiment illustrated in FIG. 3 includes the disposable housing 20, andthe disposable housing 20 in accordance with the embodiment illustratedin FIG. 3 includes a base 21 and a reservoir retaining portion 24. Inone embodiment, the base 21 and reservoir retaining portion 24 may beformed as a single, unitary structure.

The base 21 of the disposable housing 20 is configured to be secured tothe body of a user. The reservoir retaining portion 24 of the disposablehousing 20 is configured to house the reservoir. The reservoir retainingportion 24 of the disposable housing 20 may be configured to have anopening to allow for the port 41 of the reservoir 40 to be accessed fromoutside of the reservoir retaining portion 24 while the reservoir 40 ishoused in the reservoir retaining portion 24. The durable housing 30 maybe configured to be attachable to and detachable from the base 21 of thedisposable housing 20. The delivery device 12 in the embodimentillustrated in FIG. 3 includes a plunger shaft 60 that is connected toor that is connectable to a piston (not shown in FIG. 3) within thereservoir 40.

FIG. 4 illustrates another view of the delivery device 12 of theembodiment of FIG. 3. The delivery device 12 of the embodimentillustrated in FIG. 4 includes the disposable housing 20, the durablehousing 30, and the infusion path 50. The disposable housing 20 in theembodiment of FIG. 4 includes the base 21′, the reservoir retainingportion 24, and a peelable cover layer 25. The peelable cover layer 25may cover an adhesive material on the bottom surface 22 of the base 21.The peelable cover layer 25 may be configured to be peelable by a userto expose the adhesive material on the bottom surface 22 of the base 21.In some embodiments, there may be multiple adhesive layers on the bottomsurface 22 of the base 21 that are separated by peelable layers.

The infusion path 50 in accordance with the embodiment of the presentinvention illustrated in FIG. 4 includes the needle 58 rather than theconnector 56, the tube 54, and the needle apparatus 52 as shown in theembodiment of FIG. 2. The base 21 of the disposable housing 20 may beprovided with an opening or pierceable wall in alignment with a tip ofthe needle 58, to allow the needle 58 to pass through the base 21 andinto the skin of a user under the base 21, when extended. In thismanner, the needle 58 may be used to pierce the skin of the user anddeliver an infusion medium to the user.

Alternatively, the needle 58 may be extended through a hollow cannula(not shown in FIG. 4), such that upon piercing the skin of the user withthe needle 58, an end of the hollow cannula is guided through the skinof the user by the needle 58. Thereafter, the needle 58 may be removed,leaving the hollow cannula in place, with one end of the cannula locatedwithin the body of the user and the other end of the cannula in fluidflow connection with the infusion medium within the reservoir 40, toconvey pumped infusion media from the reservoir 40 to the body of theuser.

FIG. 5A illustrates a durable portion 8 of the delivery device 12 (referto FIG. 3) in accordance with an embodiment of the present invention.FIG. 5B illustrates a section view of the durable portion 8 inaccordance with an embodiment of the present invention. FIG. 5Cillustrates another section view of the durable portion 8 in accordancewith an embodiment of the present invention. With reference to FIGS. 5A,5B, and 5C, in various embodiments, the durable portion 8 includes thedurable housing 30, and a drive device 80. The drive device 80 includesa motor 84 and a drive device linkage portion 82. In variousembodiments, the durable housing 30 may include an interior volume forhousing the motor 84, the drive device linkage portion 82, otherelectronic circuitry, and a power source (not shown in FIGS. 5A, 5B, and5C). Also, in various embodiments, the durable housing 30 is configuredwith an opening 32 for receiving a plunger shaft 60 (refer to FIG. 3).Also, in various embodiments, the durable housing 30 may include one ormore connection members 34, such as tabs or the like, for connectingwith the base 21 of the disposable housing 20 (refer to FIG. 3).

FIG. 6A illustrates a disposable portion 9 of the delivery device 12(refer to FIG. 3) in accordance with an embodiment of the presentinvention. FIG. 6B illustrates a section view of the disposable portion9 in accordance with an embodiment of the present invention. FIG. 6Cillustrates another section view of the disposable portion 9 inaccordance with an embodiment of the present invention. With referenceto FIGS. 6A, 6B, and 6C, in various embodiments, the disposable portion9 includes the disposable housing 20, the reservoir 40, the plungershaft 60, and a piston 70. In some embodiments, the disposable housing20 includes the base 21 and the reservoir retaining portion 24. Invarious embodiments, the base 21 includes a top surface 23 having one ormore connection members 26, such as grooves or the like, for allowingconnections with the one or more connection members 34 of embodiments ofthe durable housing 30 (refer to FIG. 5B).

In various embodiments, the reservoir 40 is housed within the reservoirretaining portion 24 of the disposable housing 20, and the reservoir 40is configured to hold an infusion medium. Also, in various embodiments,the piston 70 is disposed at least partially within the reservoir 40 andis moveable within the reservoir 40 to allow the infusion medium to fillinto the reservoir 40 and to force the infusion medium out of thereservoir 40.

In some embodiments, the plunger shaft 60 is connected to or isconnectable to the piston 70. Also, in some embodiments, a portion ofthe plunger shaft 60 extends to outside of the reservoir retainingportion 24 of the disposable housing 20. In various embodiments, theplunger shaft 60 has a mating portion for mating with the drive devicelinkage portion 82 of the drive device 80 (refer to FIG. 5C). Withreference to FIGS. 5C and 6C, in some embodiments, the durable housing30 may be snap fitted onto the disposable housing 20, whereupon thedrive device linkage portion 82 automatically engages the mating portionof the plunger shaft 60.

When the durable housing 30 and the disposable housing 20 are fittedtogether with the drive device linkage portion 82 engaging or matingwith the plunger shaft 60, the motor 84 may be controlled to drive thedrive device linkage portion 82 and, thus, move the plunger shaft 60 tocause the piston 70 to move within the reservoir 40. When the interiorvolume of the reservoir 40 is filled with an infusion medium and aninfusion path 50 is provided from the reservoir 40 to the body of auser, the piston 70 may be moved within the reservoir 40 to force theinfusion medium from the reservoir 40 and into the infusion path 50, soas to deliver the infusion medium to the body of the user.

In various embodiments, once the reservoir 40 has been sufficientlyemptied or otherwise requires replacement, a user may simply remove thedurable housing 30 from the disposable housing 20, and replace thedisposable portion 9, including the reservoir 40, with a new disposableportion having a new reservoir. The durable housing 30 may be connectedto the new disposable housing of the new disposable portion, and thedelivery device including the new disposable portion may be secured tothe skin of a user. In various other embodiments, rather than replacingthe entire disposable portion 9 every time the reservoir 40 is emptied,the reservoir 40 may be refilled with an infusion medium. In someembodiments, the reservoir 40 may be refilled while remaining within thereservoir retaining portion 24 (refer to FIG. 6B) of the disposablehousing 20. Also, in various embodiments, the reservoir 40 may bereplaced with a new reservoir (not shown), while the disposable housing20 may be re-used with the new reservoir. In such embodiments, the newreservoir may be inserted into the disposable portion 9.

With reference to FIGS. 3, 5A, and 6B, in various embodiments, thedelivery device 12 includes reservoir status circuitry (not shown), andthe reservoir 40 includes reservoir circuitry (not shown). In variousembodiments, the reservoir circuitry stores information such as, but notlimited to, at least one of (i) an identification string identifying thereservoir 40; (ii) a manufacturer of the reservoir 40; (iii) contents ofthe reservoir 40; and (iv) an amount of contents in the reservoir 40. Insome embodiments, the delivery device 12 includes the reservoir statuscircuitry (not shown), and the reservoir status circuitry is configuredto read data from the reservoir circuitry when the reservoir 40 isinserted into the disposable portion 9. In various embodiments, thereservoir status circuitry is further configured to store data to thereservoir circuitry after at least some of the contents of the reservoir40 have been transferred out of the reservoir 40, so as to updateinformation in the reservoir circuitry related to an amount of contentsstill remaining in the reservoir 40. In some embodiments, the reservoirstatus circuitry is configured to store data to the reservoir circuitry,so as to update information in the reservoir circuitry related to anamount of contents still remaining in the reservoir 40, when thereservoir 40 is inserted into the disposable portion 9. In someembodiments, the delivery device 12 includes the reservoir statuscircuitry (not shown) and the reservoir 40 includes the reservoircircuitry (not shown), and the reservoir status circuitry selectivelyinhibits use of the delivery device 12 or selectively provides a warningsignal based on information read by the reservoir status circuitry fromthe reservoir circuitry.

Various systems, structures, and methods allowing for reservoir fillingwill now be discussed in more detail.

FIG. 7 illustrates a block diagram of a system 100 in accordance with anembodiment of the present invention. In various embodiments, the system100 includes a reservoir filling system that allows for filling areservoir, or the like. Also, in various embodiments, the system 100includes a delivery device, such as the delivery device 12, or the like.In some embodiments, the system 100 includes an infusion medium deliverysystem, such as the infusion medium delivery system 10, or the like. Inthe embodiment illustrated in FIG. 7, the system 100 includes thereservoir 40, the piston 70, the plunger shaft 60, and a handle 110.Also, in the embodiment illustrated in FIG. 7, the plunger shaft 60includes a plunger shaft mating portion 62, and the handle 110 includesa handle mating portion 112.

In various embodiments, the reservoir 40 is configured to hold aninfusion medium. In various embodiments, the reservoir 40 is made of,for example, a suitable metal, plastic, ceramic, glass, compositematerial, or the like. In some embodiments, the reservoir 40 includes acanister or the like. Also, in some embodiments, the reservoir 40 has ahollow interior for containing or holding the infusion medium. Thereservoir 40 may have a port 41 (refer to FIGS. 7 and 8) that allows forthe infusion medium to flow into and/or out of the reservoir 40.

In some embodiments, the reservoir 40 includes a septum 43 (refer toFIGS. 7 and 9) that is positioned within an opening defined by the port41 of the reservoir 40, where the septum 43 is capable of being piercedto allow the infusion medium to flow into the reservoir 40, and wherethe septum 43 is capable of holding the infusion medium within thereservoir 40 when the septum 43 is not pierced. In various embodiments,the septum 43 may be compressed around a needle (not shown in FIG. 7)that pierces the septum 43 for sealing against the needle and may be aself-sealing septum that re-seals itself, after removal of the needle.In some embodiments, the septum 43 may be compressed to provide a betterseal around the needle. Also, in various embodiments, the septum 43 isformed of a suitable material such as, but not limited to, rubber,silicone rubber, polyurethane, or other materials that may be pierced bya needle and form a seal around the needle.

In various embodiments, the reservoir 40 includes a reservoir degassingportion 42. In such embodiments, the reservoir degassing portion 42allows for gases to be released from the reservoir 40 while maintainingan infusion medium, such as liquids or the like, within the interiorvolume of the reservoir 40. In some embodiments, the reservoir degassingportion 42 includes a hydrophobic material or the like that will allowfor air and other gases to pass through, but will not allow liquids,such as water, syringe deliverable insulin, or the like, to passthrough. Also, in some embodiments, the reservoir degassing portion 42includes a material such as a hydrophobic membrane, or the like, that ismanufactured by Gore™. Such a reservoir degassing portion 42 may bepositioned in any suitable position with respect to the reservoir 40 andmay extend from an interior surface of the reservoir 40 to an exteriorsurface of the reservoir 40 to allow for gases to pass from the interiorvolume of the reservoir 40 to outside of the reservoir 40, so as toallow for degassing the interior volume of the reservoir 40. Examples offurther structures that permit air-flow, but that inhibit fluids can befound in U.S. patent application Ser. No. 10/328,393 filed Dec. 22,2003, and entitled “Reservoir Connector,” and U.S. patent applicationSer. No. 10/699,429 filed Oct. 31, 2003, and entitled “External InfusionDevice with a Vented Housing,” both of which are incorporated herein byreference in their entirety.

In various embodiments that include the reservoir degassing portion 42,once gases are removed from the interior volume of the reservoir 40through the reservoir degassing portion 42, the reservoir 40 is sealedto prevent gases from re-entering the reservoir 40 and to preventevaporation of an infusion medium in the reservoir 40. In someembodiments that include the reservoir degassing portion 42, thereservoir degassing portion 42 is used to degas the reservoir 40 withpositive pressure and then is removed or covered to prevent evaporationof an infusion medium that is in the reservoir 40.

In various embodiments, the piston 70 (refer to FIGS. 7, 8, and 9) isdisposed at least partially within the reservoir 40, where the piston 70is moveable to allow the infusion medium to fill into the reservoir 40and to force the infusion medium out of the reservoir 40. The piston 70may be made of a suitably rigid material such as, but not limited to,metal, plastic, ceramic, glass, a composite material, or the like. Insome embodiments, the piston 70 has a head with an outside diameter ofslightly less than the inside diameter of the interior of the reservoir40. In other embodiments, the piston 70 has a head with an outsidediameter of slightly greater than or equal to the inside diameter of theinterior of the reservoir 40, and the piston 70 may be compressible tofit within the reservoir 40. In various embodiments, the piston 70extends partially into the interior of the reservoir 40 from an oppositeside of the reservoir 40 relative to the port 41 of the reservoir 40.

In various embodiments, the piston 70 includes a piston degassingportion 72 (refer to FIGS. 7 and 9). In such embodiments, the pistondegassing portion 72 allows for gases to be released from the reservoir40 through an opening in the piston 70 while maintaining an infusionmedium, such as liquids or the like, within the interior volume of thereservoir 40. In some embodiments, the piston degassing portion 72includes a hydrophobic material or the like that will allow for air andother gases to pass through, but will not allow liquids, such as water,syringe deliverable insulin, or the like, to pass through. Also, in someembodiments, the piston degassing portion 72 includes a material such asa hydrophobic membrane, or the like, that is manufactured by Gore™.Examples of structures that permit air-flow, but that inhibit fluids canbe found in U.S. patent application Ser. No. 10/328,393 filed Dec. 22,2003, and entitled “Reservoir Connector,” and U.S. patent applicationSer. No. 10/699,429 filed Oct. 31, 2003, and entitled “External InfusionDevice with a Vented Housing,” both of which are incorporated herein byreference in their entirety. Such a piston degassing portion 72 may bepositioned in any suitable position with respect to the piston 70 andmay extend from a first surface of the piston 70 that faces the interiorvolume of the reservoir 40 to a second surface of the piston 70 that isopposite the first surface, to allow for gases to pass from the interiorvolume of the reservoir 40 to outside of the reservoir 40, so as toallow for degassing the interior volume of the reservoir 40.

In various embodiments that include the piston degassing portion 72,once gases are removed from the interior volume of the reservoir 40through the piston degassing portion 72, the piston 70 is sealed toprevent gases from re-entering the reservoir 40 and to preventevaporation of an infusion medium in the reservoir 40. In someembodiments that include the piston degassing portion 72, the pistondegassing portion 72 is used to degas the reservoir 40 with positivepressure and then is removed or covered to prevent evaporation of aninfusion medium that is in the reservoir 40.

In various embodiments, the plunger shaft 60 (refer to FIGS. 7, 8, and9) is connected to the piston 70. In some embodiments, the plunger shaft60 is formed as a single unit with the piston 70. In various otherembodiments, the plunger shaft 60 is attached to the piston 70 by, forexample, an adhesive, a screw, joining engagement portions of theplunger shaft 60 and the piston 70, or the like. The plunger shaft 60may be made of a suitably rigid material such as, but not limited to,metal, plastic, ceramic, glass, a composite material, or the like.

In some embodiments, the plunger shaft 60 includes the plunger shaftmating portion 62. In such embodiments, the plunger shaft mating portion62 is configured to allow for mating with a linkage portion of a drivedevice, such as the drive device linkage portion 82 of the drive device80 (refer to FIGS. 7, 8, and 9). In various embodiments, the drivedevice 80 allows for driving the plunger shaft 60 so as to move thepiston 70 to force the infusion medium out of the reservoir 40 when thedrive device linkage portion 82 of the drive device 80 is mated with theplunger shaft mating portion 62 of the plunger shaft 60. In someembodiments, the plunger shaft mating portion 62 is provided withthreads, keys, key slots, or the like, that are configured tooperatively engage or mate with corresponding threads, keys, key slots,or the like, of the drive device linkage portion 82. In someembodiments, the plunger shaft 60 includes a partial nut, a lead screw,or the like.

The handle 110 includes the handle mating portion 112 (refer to FIGS. 7,12, 13, and 30). The handle 110 may be made of a suitably rigid materialsuch as, but not limited to, metal, plastic, ceramic, glass, a compositematerial, or the like. The handle mating portion 112 of the handle 110is configured to allow for mating with the plunger shaft mating portion62 of the plunger shaft 60. In some embodiments, the handle matingportion 112 is provided with threads, keys, key slots, or the like, thatare configured to operatively engage or mate with corresponding threads,keys, key slots, or the like, of the plunger shaft mating portion 62. Invarious embodiments, the handle mating portion 112 of the handle 110includes a lead screw, a partial nut, or the like.

The handle 110 is capable of being used by a user to move the plungershaft 60 so as to move the piston 70 to allow the infusion medium toflow or fill into the reservoir 40 when the handle mating portion 112 ofthe handle 110 is mated with the plunger shaft mating portion 62 of theplunger shaft 60. The handle mating portion 112 of the handle 110 may bemated with the plunger shaft mating portion 62 of the plunger shaft 60when the drive device linkage portion 82 of the drive device 80 has beendisconnected or disengaged from the plunger shaft mating portion 62 ofthe plunger shaft 60.

In various embodiments, the handle 110 further includes a gripping arm114 for gripping the plunger shaft 60 when the handle mating portion 112of the handle 110 is mated with the plunger shaft mating portion 62 ofthe plunger shaft 60. In some embodiments, the plunger shaft matingportion 62 includes a partial nut, the handle mating portion 112includes a threaded interface, and the gripping arm 114 extends from thehandle mating portion 112 of the handle 110. In such embodiments, thehandle mating portion 112 may be mated with the plunger shaft matingportion 62 and then rotated to cause the gripping arm 114 to grip theplunger shaft 60 between the gripping arm 114 and the handle matingportion 112 of the handle 110.

In various embodiments, the system 100 further includes the drive device80 (refer to FIGS. 7, 8, and 9). In some embodiments, the drive device80 includes the drive device linkage portion 82 and the motor 84. Themotor 84 may be mechanically coupled to the drive device linkage portion82 to drive the drive device linkage portion 82 in a controlled manner.For example, the drive device linkage portion 82 may include a threadedlead screw, and the motor 84 may drive the lead screw in a rotary motionabout its longitudinal axis. The drive device linkage portion 82 mayinclude one or more suitable gears, belts, chains, drive shafts, orother linkage structures for coupling to the motor 84. Examples ofsuitable motors that may be used for the motor 84 include, but are notlimited to, a DC motor, a flat or pancake DC motor, a servo motor, astepper motor, an electronically commutated motor, a rotarypiezo-electrically actuator motor, and the like. In some embodiments,the drive device linkage portion 82 is provided with threads, keys, keyslots, or the like, that are configured to operatively engage or matewith corresponding threads, keys, key slots, or the like, of the plungershaft mating portion 62. In various embodiments, the drive devicelinkage portion 82 includes a lead screw, a partial nut, or the like.

In some embodiments, the system 100 further includes the infusion path50. In some embodiments, the infusion path 50 includes the connector 56,the tube 54, and the needle apparatus 52 as illustrated in FIG. 2, forconnecting to the port 41 of the reservoir 40 and for providing a pathto deliver the infusion medium from the reservoir 40 to the body of auser. Also, in various embodiments, the infusion path 50 includes theneedle 58 as illustrated in FIG. 4 for providing a path to deliver theinfusion medium from the reservoir 40 to the body of the user through anopening in the base of a disposable housing. In various embodiments, theport 41 of the reservoir 40 is connectable to the infusion path 50 toallow for delivering the infusion medium from the reservoir to the bodyof a particular user, where the port 41 is also connectable to atransfer path, such as a transfer guard 120 or the like, to allow theinfusion medium to be transferred into the reservoir 40 from an infusionmedium container (not shown in FIG. 7), such as a vial, a canister, orthe like.

In various embodiments, the system 100 further includes the transferdevice, referred to herein as a transfer guard 120 (refer to FIGS. 7 and10-13). In some embodiments, the transfer guard 120 is connectable tothe port 41 of the reservoir 40 for providing a path to allow theinfusion medium to be transferred from an infusion medium container tothe reservoir 40. In various embodiments, the transfer guard 120 isconfigured like one or more of the embodiments of the transfer guard asdisclosed in U.S. Pat. No. 6,591,876, entitled “Needle Safe TransferGuard”, the contents of which are incorporated by reference herein. Insome embodiments, the transfer guard 120 includes a degassing portion(not shown) that allows for the reservoir 40 to be filled with aninfusion medium and then allows for the reservoir 40 to be degassed, andthen is removed to allow the reservoir 40 to be sealed.

In some embodiments, the system 100 further includes the disposablehousing 20. In various embodiments, the disposable housing includes thebase 21. Also, in various embodiments, the reservoir 40, the piston 70,and the plunger shaft 60 are supported by the base 21 of the disposablehousing 20. In some embodiments, the base 21 of the disposable housing20 is adapted to be secured to a user, such as with an adhesive, or thelike. Also, in some embodiments, the reservoir 40 is connected to thebase 21 of the disposable housing 20.

In various embodiments, the system 100 further includes the durablehousing 30. In some embodiments, the drive device 80 and electroniccircuitry 17 are housed or contained within the durable housing 30. Invarious embodiments of the system 100, the durable housing 30 and thedisposable housing 20 are configured as in the embodiment of thedelivery device 12 illustrated in FIG. 2. In various other embodimentsof the system 100, the durable housing 30 and the disposable housing 20are configured as in the embodiment of the delivery device 12illustrated in FIG. 3.

In some embodiments, the system 100 further includes the electroniccircuitry 17. In various embodiments, the electronic circuitry 17 may beconfigured to control the motor 84 according to a desired infusionmedium delivery program or profile. A delivery program or profile may bestored within a suitable electronic storage medium (not shown) locatedwithin the durable housing 30 and/or may be communicated to theelectronic circuitry 17 from other sources, such as the CCD 16 or thesensing device 14 or the computer 18 shown in FIG. 1. Alternatively, orin addition, the electronic circuitry 17 may control the motor 84 todeliver one or more discrete volumes of the infusion medium in responseto delivery demand control signals generated within the system 100 orcommunicated to the system 100 from other sources. In variousembodiments, the electronic circuitry 17 may be housed or containedwithin the durable housing 30.

FIG. 8 illustrates a portion of an embodiment of the system 100 inaccordance with an embodiment of the present invention. In theembodiment illustrated in FIG. 8, the reservoir 40 has the port 41, andthe piston 70 is disposed within the reservoir 40. In variousembodiments, the reservoir 40 defines an infusion medium retaininginterior volume or portion 44 for holding or containing an infusionmedium. In some embodiments, one or more seals 73 may be provided aroundan outer peripheral surface of the piston 70, to inhibit a passage ofthe infusion medium across the piston 70 from the infusion mediumretaining interior portion 44 of the reservoir 40 to outside of thereservoir 40.

In various embodiments, the seals 73 may include one or more o-ringseals or other suitable seal structures and may be made of any suitablematerial, including but not limited to, rubber, silicone rubber,polyurethane or other plastic material, metal, composite material, orthe like. In some embodiments, the seals 73 may provide sufficientfrictional force between the piston 70 and an interior surface of thereservoir 40 to inhibit rotation of the piston 70 with respect to thereservoir 40. Also, in various embodiments, additional structure may beprovided to inhibit rotation of the piston 70 with respect to thereservoir 40 including, but not limited to, one or more keys,projections, or shaped portions on the piston 70 that fit withincorresponding one or more grooves along a length of the interior surfaceof the reservoir 40, or vice versa. For example, the interior surface ofthe reservoir 40 may have a groove, and the piston 70 may have acorresponding projection that fits slidably within the groove, such thatthe piston 70 is able to slide within the reservoir 40, but is not ableto rotate within the reservoir 40. In yet further embodiments, the crosssectional shape of the piston 70 and of the reservoir 40 may benon-circular, such as, but not limited to, oval, to inhibit rotation ofthe piston 70 with respect to the reservoir 40. Such a non-circularcross-sectional shape of the piston 70 and of the reservoir 40 may alsominimize an overall height the piston 70 and the reservoir 40.

In the embodiment illustrated in FIG. 8, the plunger shaft 60 is formedas a single unit with the piston 70. Also, in the embodiment illustratedin FIG. 8, the plunger shaft 60 has the plunger shaft mating portion 62that includes a partial nut that is threaded along the longitudinaldirection of the plunger shaft 60. Moreover, in the embodimentillustrated in FIG. 8, the drive device linkage portion 82 of the drivedevice 80 includes a rotatably driven drive shaft 86 on which a drivescrew 85 is mounted. In various embodiments, the drive screw 85 of thedrive device linkage portion 82 is threaded. During operation of theembodiment illustrated in FIG. 8, the drive screw 85 of the drive devicelinkage portion 82 is arranged to mate with the plunger shaft matingportion 62 and, upon rotation of the drive shaft 86 by the motor 84, thedrive screw 85 is rotated to cause a linear movement of the plungershaft 60 relative to the reservoir 40 and, as a result, the piston 70 ismoved within the reservoir 40.

In various embodiments, the reservoir 40 may be supported by the base 21of the disposable housing 20, while the motor 84 along with the driveshaft 86 and the drive screw 85 may be supported within the durablehousing 30. In such embodiments, when the durable housing 30 is removedfrom the disposable housing 20, the drive screw 85 may be easilydisengaged or disconnected from the plunger shaft mating portion 62 ofthe plunger shaft 60 by simply lifting the drive screw 85 off of theplunger shaft mating portion 62. Also, in various embodiments, theplunger shaft 60 is positioned with respect to the disposable housing 20such that when the durable housing 30 is connected to the disposablehousing 30, the drive screw 85 automatically mates with the plungershaft mating portion 62 of the plunger shaft 60.

FIG. 9 illustrates a portion of an embodiment of the system 100 inaccordance with another embodiment of the present invention. In theembodiment illustrated in FIG. 9, the reservoir 40 has the port 41 andfurther has a second port 45. In the embodiment of FIG. 9, the septum 43is located within the port 41, and a second septum 46 is located withinthe second port 45. In various embodiments, the port 41 is connectableto an embodiment of the infusion path 50 that includes the connector 56,the tube 54, and the needle apparatus 52 (refer to FIG. 2). Also, invarious embodiments, the second port 45 is connectable to an embodimentof the infusion path 50 that includes the needle 58 (refer to FIG. 4).In some embodiments, the reservoir 40 is filled with an infusion mediumthrough the port 41 and the infusion medium is forced out of thereservoir 40 through the second port 45. The embodiment of the reservoir40 illustrated in FIG. 9 may be said to be a multi-port reservoir,because the reservoir 40 has two ports.

In the embodiment illustrated in FIG. 9, the piston 70 is disposedwithin the reservoir 40, and the plunger shaft 60 is formed as a singleunit with the piston 70. In the embodiment illustrated in FIG. 9, theplunger shaft 60 has the plunger shaft mating portion 62 that includes athreaded rack that is threaded along the longitudinal direction of theplunger shaft 60. Moreover, in the embodiment illustrated in FIG. 9, thedrive device linkage portion 82 of the drive device 80 includes arotatably driven drive shaft 88 on which a pinion gear 87 is fixedlymounted for rotation with rotation of the drive shaft 88. Duringoperation of the embodiment illustrated in FIG. 9, the pinion gear 87 ofthe drive device linkage portion 82 is arranged to mate with the plungershaft mating portion 62 and, upon rotation of the drive shaft 88 by themotor 84, the pinion gear 87 is rotated to cause a linear movement ofthe plunger shaft 60 relative to the reservoir 40 and, as a result, thepiston 70 is moved within the reservoir 40.

In various embodiments, the reservoir 40 may be supported by the base 21of the disposable housing 20, while the motor 84 along with the driveshaft 88 and the pinion gear 87 may be supported within the durablehousing 30. In such embodiments, when the durable housing 30 is removedfrom the disposable housing 20, the pinion gear 87 may be easilydisengaged or disconnected from the plunger shaft mating portion 62 ofthe plunger shaft 60 by simply lifting the pinion gear 87 off of theplunger shaft mating portion 62. Also, in various embodiments, theplunger shaft 60 is positioned with respect to the disposable housing 20such that when the durable housing 30 is connected to the disposablehousing 30, the pinion gear 87 automatically mates with the plungershaft mating portion 62 of the plunger shaft 60.

FIG. 10 illustrates another portion of an embodiment of the system 100in accordance with an embodiment of the present invention. In theembodiment illustrated in FIG. 10, the system 100 includes the reservoir40, the plunger shaft 60, and the transfer guard 120. In variousembodiments, the system 100 further includes an infusion mediumcontainer 130. The infusion medium container 130 allows for holding aninfusion medium. In various embodiments, the infusion medium container130 includes a vial, a canister, or the like. Also, in variousembodiments, the infusion medium container 130 is made of a suitablematerial such as, but not limited to, metal, plastic, ceramic, glass,composite material, or the like. In some embodiments, the infusionmedium container 130 is configured with an opening, and a septum 132that is able to be pierced by a needle is located within or over theopening in the infusion medium container 130, and the infusion medium isable to flow out of the opening in the infusion medium container 130when the septum 132 is pierced.

In various embodiments, the transfer guard 120 includes a supply adapter122, a receiver adapter 124, a support structure 126, and an infusionmedium conducting element 128. In some embodiments, the supply adapter122 is adapted to be mated with the infusion medium container 130. Also,in some embodiments, the receiver adapter 124 is adapted to be matedwith the reservoir 40. In various embodiments, the support structure 126is coupled between the supply adapter 122 and the receiver adapter 124,where the support structure 126 is configured to allow movement of thesupply adapter 122 and the receiver adapter 124 from a first moredistant position relative to each other to a second closer positionrelative to each other.

Also, in various embodiments, the infusion medium conducting element 128includes a needle or the like that extends from the supply adapter 122to the receiver adapter 124. In some embodiments, the supply adapter 122and the receiver adapter 124 are further adapted to substantiallyprotect the corresponding tips of the infusion medium conducting element128, such as needle tips, from contact with a user. In variousembodiments, the infusion medium conducting element 128 is able topierce the septum 132 of the infusion medium container 130 and is ableto pierce the septum 43 of the reservoir 40, so as to establish atransfer path for transferring an infusion medium from the infusionmedium container 130 to the reservoir 40.

FIG. 11 illustrates a portion of an embodiment of the system 100 inaccordance with the embodiment shown in FIG. 10, where the transferelement 120 has been mated with the infusion medium container 130 andwith the reservoir 40. As is illustrated in FIG. 11, in variousembodiments, the supply adapter 122 is able to mate with the infusionmedium container 130 and the receiver adapter 124 is able to mate withthe reservoir 40, such that the infusion medium conducting elementprovides a transfer path from the infusion medium container 130 to thereservoir 40. In some embodiments, the reservoir 40 includes an openingout of which the plunger shaft 60 extends, where the receiver adapter124 of the transfer guard 120 is connectable to an opposite side of thereservoir 40 from a side of the reservoir 40 that has the opening out ofwhich the plunger shaft 60 extends.

FIG. 12 illustrates another portion of an embodiment of the system 100in accordance with an embodiment of the present invention. In theportion of the system 100 illustrated in the embodiment of FIG. 12, thesystem 100 includes the infusion medium container 130, the transferguard 120, the reservoir 40, the plunger shaft 60, and the handle 110.In the embodiment of the system 100 illustrated in FIG. 12, the plungershaft mating portion 62 of the plunger shaft 60 includes a threadedpartial nut, and the handle mating portion 112 of the handle 110includes a threaded interface. The handle mating portion 112 of thehandle 110 is configured to be mated with the plunger shaft matingportion 62 of the plunger shaft. In various embodiments, the handlemating portion 112 is mated with the plunger shaft mating portion 62 byplacing the handle mating portion 112 on the plunger shaft matingportion 62.

Placing the handle mating portion 112 on the plunger shaft matingportion 62 is only an example of a method of mating the handle 110 withthe plunger shaft 60, and various other embodiments of the presentinvention are not limited to such a mating method. For example, variousother embodiments may provide for the handle mating portion 112 and theplunger shaft mating portion 62 to be keyed, and for the handle matingportion 112 and the plunger shaft mating portion 62 to be mated byjoining the keyed portions of each together. Also, various otherembodiments may provide for the handle mating portion 112 to include aprotrusion and for the plunger shaft mating portion 62 to include acorresponding groove so that the handle mating portion 112 is able to bemated with the plunger shaft mating portion 62 by placing the protrusionof the handle mating portion 112 in the groove of the plunger shaftmating portion 62. Various other mating methods are also possible.

In various embodiments, the handle 110 includes the gripping arm 114 forgripping the plunger shaft 60 when the handle mating portion 112 of thehandle 110 is mated with the plunger shaft mating portion 62 of theplunger shaft 60. Also, in various embodiments, the handle 110 furtherincludes a bar 116 connected to the handle mating portion 112, where thebar 116 is able to be gripped by the hand of a user to pull or push thehandle 110 when the handle mating portion 112 is mated with the plungershaft mating portion 62.

FIG. 30 illustrates another embodiment of the handle 110 in accordancewith an embodiment of the present invention. The handle 110 illustratedin FIG. 30 includes the bar 116, the handle mating portion 112, and thegripping arm 114. The gripping arm 114 of the embodiment of the handle110 in FIG. 30 is a skirt or sleeve that surrounds the handle matingportion 112.

FIG. 13 illustrates a portion of an embodiment of the system 100 inaccordance with the embodiment shown in FIG. 12, where the handle matingportion 112 of the handle 110 has been mated with the plunger shaftmating portion 62 of the plunger shaft 60. As is illustrated in FIG. 13,in various embodiments, the handle mating portion 112 of the handle 110is threaded and the plunger shaft mating portion 62 of the plunger shaft60 is threaded, such that the handle mating portion 112 is able to matewith the plunger shaft mating portion 62 when the handle mating portion112 is placed on the plunger shaft mating portion 62. In someembodiments, when the handle mating portion 112 is mated with theplunger shaft mating portion 62, the gripping arm 114 of the handle 110is able to surround a perimeter of the plunger shaft 60 by 180° or morearound the perimeter. In other embodiments, when the handle matingportion 112 is mated with the plunger shaft mating portion 62, thegripping arm 114 of the handle 110 is able to surround a perimeter ofthe plunger shaft 60 by only less than 180° around the perimeter. Insome embodiments, when the handle mating portion 112 is mated with theplunger shaft mating portion 62, the gripping arm 114 of the handle 110is able to surround a perimeter of the plunger shaft 60 by 360° aroundthe perimeter.

In various embodiments, the handle 110 may be rotated when the handlemating portion 112 is mated with the plunger shaft mating portion 62such that the handle 110 is positioned in a location where at least aportion of the plunger shaft 60 is located between the gripping arm 114and at least a portion of the handle mating portion 112. Also, invarious embodiments, the gripping arm 114 of the handle 110 may bebiased so as to grip the plunger shaft 60 when the plunger shaft 60 islocated between at least a portion of the gripping arm 114 and at leasta portion of the handle mating portion 112. By gripping the plungershaft 60 between at least a portion of the gripping arm 114 and at leasta portion of the handle mating portion 112, the handle 110 may beprevented from disconnecting from the plunger shaft 60 until the handle110 is rotated to a position where the plunger shaft 60 is not betweenthe gripping arm 114 and the handle mating portion 112.

FIG. 14 illustrates a flow chart of a method of using an embodiment ofthe system 100 in accordance with an embodiment of the presentinvention. In describing the embodiment of the method illustrated by theflow chart in FIG. 14, reference will be made to various elements ofembodiments of the system 100 illustrated in FIGS. 7-13. In S10, thehandle mating portion 112 of the handle 110 is mated with the plungershaft mating portion 62 of the plunger shaft 60, so as to connect thehandle 110 to the plunger shaft 60. In various embodiments, the stepS110 includes the step S11 of mating the handle mating portion 112 ofthe handle 110 with the plunger shaft mating portion 62 of the plungershaft 60, and the step S12 of rotating the handle 110 so as to positionthe gripping arm 114 of the handle 110 in a position to grip the plungershaft 60. The method then continues to S13.

In S13, a transfer path for transferring an infusion medium from theinfusion medium container 130 to the reservoir 40 is established. Invarious embodiments, the step S13 includes the step S14 of connectingthe transfer guard 120 to the port 41 of the reservoir 40, and the stepS15 of connecting the infusion medium container 130 to the transferguard 120. In some embodiments, the steps S10 and S13 are reversed suchthat a transfer path is established between the infusion mediumcontainer 130 and the reservoir 40 before the handle mating portion 112is mated with the plunger shaft mating portion 62. The method thencontinues to S16.

In S16, the handle 110 is pulled to move the plunger shaft 60 so as tomove the piston 70 to allow the infusion medium to flow or fill into thereservoir 40 from the infusion medium container 130, and the methodcontinues to S17. In S17, the transfer guard 120 is disconnected fromthe port 41 of the reservoir 40, and the method continues to S18. InS18, the handle 110 is disconnected from the plunger shaft 60. Themethod then continues to S119.

In S19, the port 41 of the reservoir 40 is connected to the infusionpath 50 that allows for a transfer of the infusion medium from thereservoir 40 to the body of a user, and the method continues to S20. InS20, the drive device linkage portion 82 of the drive device 80 is matedwith the plunger shaft mating portion 62 of the plunger shaft 60 afterthe handle 110 has been disconnected from the plunger shaft 60. Themethod then continues to S21. In S21, the motor 84 is controlled to movethe drive device linkage portion 82 of the drive device 80 to move theplunger shaft 60 so as to move the piston 70 to force the infusionmedium out of the reservoir 40. The method then ends in S22.

In accordance with the embodiment of the method of using the system 100illustrated in FIG. 14, the reservoir 40 is able to be filled with aninfusion medium from the infusion medium container 130. In variousembodiments, the reservoir 40 is housed in the reservoir retainingportion 24 of the disposable housing 20 (refer to FIGS. 6A and 6B), andthe reservoir retaining portion 24 has an opening such that thereservoir 40 is able to be filled with an infusion medium from theinfusion medium container 130 while the reservoir 40 is located withinthe reservoir retaining portion 24 of the disposable housing 20.

In various embodiments, the reservoir 40 is able to be refilled with aninfusion medium using the method illustrated in FIG. 14. Thus, invarious embodiments, the system 100 allows for filling and/or refillingof the reservoir 40. In some embodiments, the reservoir 40 may bepartially filled with the infusion medium, while in other embodiments,the reservoir 40 may be completely filled with the infusion medium.Also, in some embodiments, the reservoir 40 may have measurement marksprinted on a surface of the reservoir 40 so that the reservoir 40 can befilled with a measured amount of an infusion medium. Moreover, invarious embodiments, the handle 110 is able to be pushed when the handlemating portion 112 is mated with the plunger shaft mating portion 62 soas to advance the piston 70 within the reservoir 40.

FIG. 15 illustrates a block diagram of a system 200 in accordance withan embodiment of the present invention. In various embodiments, thesystem 200 includes a reservoir filling system that allows for filling areservoir, or the like. Also, in various embodiments, the system 200includes a delivery device, such as the delivery device 12 (refer toFIGS. 2 and 3), or the like. In some embodiments, the system 200includes an infusion medium delivery system, such as the infusion mediumdelivery system 10 (refer to FIG. 1), or the like. In variousembodiments, the system 200 includes the reservoir 40 and the piston 70.Also, in various embodiments, the system 200 further includes theplunger shaft 60, the drive device 80, the infusion path 50, thedisposable housing 20, the durable housing 30, the electronic circuitry17, and a fill apparatus 210.

In various embodiments, the piston 70 includes a piston body 74 forforcing an infusion medium out of the reservoir 40. Also, in variousembodiments, the piston body 74 is configured to have an opening. Insome embodiment, the piston body 74 is configured to have an openingfrom a first surface of the piston body 74 that faces an infusion mediumretaining interior volume 44 (refer to FIG. 8) of the reservoir 40 to asecond surface of the piston body 74 that faces away from the infusionmedium retaining interior volume 44 of the reservoir 40.

In various embodiments, the piston body 74 is configured to have anopening and the piston 70 further includes a piston septum 76 that iscapable of being pierced to allow an infusion medium to be filled intoor flow into the reservoir 40 through the opening in the piston body. Insome embodiments, the piston septum 76 is located within an opening inthe piston body 74. Also, in some embodiments, the piston septum 76covers an opening in the piston body 74. In various embodiments, thepiston septum 76 is formed of a suitable material such as, but notlimited to, rubber, silicone rubber, polyurethane, or other materialsthat may be pierced by a needle and form a seal around the needle. Also,in various embodiments, the piston septum 76 is a self-sealing septum,such that the piston septum 76 closes so as to create a seal when thepiston septum 76 is not being pierced.

Moreover, in various embodiments, the piston body 74 includes a pistonbody engagement portion 75 and the plunger shaft 60 includes a plungershaft engagement portion 64, where the plunger shaft engagement portion64 is able to be engaged with the piston body engagement portion 75. Invarious embodiments, the plunger shaft engagement portion 64 of theplunger shaft 60 includes a threaded screw or the like, and the pistonbody engagement portion 75 includes a threaded receptacle or the likefor receiving the threaded screw of the plunger shaft engagement portion64. Various other embodiments of the system 200 may have differentstructures for allowing for engagement of the piston body 74 with theplunger shaft 60, such as keyed structures, a tongue and groovestructure, or the like.

In various embodiments of the system 200, the fill apparatus 210includes a transfer element 212, such as a needle or the like, that iscapable of piercing the piston septum 76. In further embodiments of thesystem 200, the fill apparatus 210 further includes a fill apparatusengagement portion 211, and the piston body 74 includes the piston bodyengagement portion 75, where the fill apparatus engagement portion 211of the fill apparatus 210 is able to be engaged with the piston bodyengagement portion 75 of the piston body 74. In various embodiments, thefill apparatus engagement portion 211 includes a threaded portion, akeyed portion, a protrusion, a groove, or the like.

In various embodiments, the fill apparatus 210 further includes acovering portion 214 for at least partially surrounding a first end ofthe transfer element 212. Also, in various embodiments, the coveringportion 214 is configured to be able to be placed over at least aportion of an infusion medium container, such as the infusion mediumcontainer 130 (refer to FIG. 10). In some embodiments, the fillapparatus 210 further includes a compressible portion 213 that is ableto be compressed. In various embodiments, the compressible portion 213includes a bellows or the like that is connected to the covering portion214 and to the transfer element 212. Also, in various embodiments, thepiston 70 includes the piston septum 76 and the piston body 74 with thepiston body engagement portion 75, and the fill apparatus 210 isconfigured such that the transfer element 212 pierces the piston septum76 when (i) the fill apparatus engagement portion 211 is engaged withthe piston body engagement portion 75 and (ii) the compressible portion213 of the fill apparatus 210 is compressed. In various embodiments, thefill apparatus 210 includes one or more of metal, plastic, rubber,glass, or the like.

FIG. 16 illustrates a portion of an embodiment of the system 200 inaccordance with an embodiment of the present invention. As isillustrated in FIG. 16, in various embodiments, the piston 70 includesthe piston body 74 with an opening, and also includes the piston septum76 located at least partially within the opening in the piston body 74.In the embodiment illustrated in FIG. 16, the piston body 74 includesthe piston body engagement portion 75 and the fill apparatus 210includes the fill apparatus engagement portion 211, where the fillapparatus engagement portion 211 is able to be engaged with the pistonbody engagement portion 75. Also, in the embodiment illustrated in FIG.16, the piston body engagement portion 75 includes a threadedreceptacle, and the fill apparatus engagement portion 211 includes athreaded portion that is able to be screwed into the threaded receptacleof the piston body engagement portion 75. Various other embodiments mayemploy, for example, keyed structures, tongue and groove structures, orthe like, for allowing the fill apparatus 210 to engage with the pistonbody 74.

In various embodiments of the system 200, the system 200 includes thefill apparatus 210 with the covering portion 214 and the coveringportion 214 is capable of fitting over a vial, such as a 10 ml insulinvial, or the like. Also, in various embodiments of the system 200, thepiston 70 includes the piston septum 76, and the fill apparatus 210includes the covering portion 214 and the compressible portion 213. Insuch embodiments, the fill apparatus may be configured so that once thecovering portion 214 has covered an infusion medium container, such as avial or the like, and a user pushes on the infusion medium container,the compressible portion 213 is compressed to cause the transfer element212 to pierce the piston septum 76 and establish a transfer path totransfer an infusion medium from the infusion medium container to thereservoir 40.

In the embodiment of the system 200 illustrated in FIG. 16, once thecovering portion 214 has been placed over an infusion medium containerand the piston septum 76 has been pierced with the transfer element 212of the fill apparatus 210, the transfer element 212 provides a transferpath for transferring an infusion medium from the infusion mediumcontainer to the reservoir 40 through an opening in the piston body 74.Then, the fill apparatus 210 and the reservoir 40 may be oriented suchthat the fill apparatus 210 is above the reservoir 40, and the fillapparatus 210 may be pulled to cause fluid to flow out of the infusionmedium container and into the reservoir 40. In some alternateembodiments, the fill apparatus 210 and the reservoir 40 may be orientedsuch that the fill apparatus 210 is below the reservoir 40, and fluidmay be drawn from the infusion medium container into the reservoir 40.In such alternate embodiments, the transfer element 212 may need to belonger than in embodiments where, for filling the reservoir 40, thereservoir 40 is oriented such that the fill apparatus 210 is above thereservoir 40. Thus, various embodiments of the system 200 allow forfilling the reservoir 40 with an infusion medium through the piston body74, which allows for filling the reservoir 40 without having to fill thereservoir 40 through the port 41.

Thus, various embodiments of the system 200 allow for an infusion path,such as the infusion path 50 (refer to FIG. 2), from the reservoir 40 toa user to be isolated from a filling process to fill the reservoir 40,because the reservoir 40 may be filled with an infusion medium throughthe opening in the piston body 74, which is a different opening than theport 41 of the reservoir 40 from which the infusion path may receive theinfusion medium. Also, embodiments of the system 200 that use a needlefor the transfer element 212 of the fill apparatus 210 allow forprotecting a user from contact with the needle by providing the coveringportion 214 and by providing the compressible portion 213 that expandswhen the fill apparatus 210 is not being compressed to cause the needleto be covered. Thus, various embodiments of the system 200 allow formaking a filling process safer by protecting a user from contact with aneedle used as the transfer element 212.

FIG. 17 illustrates another portion of an embodiment of the system 200in accordance with an embodiment of the present invention. Withcomparison to FIG. 16, the embodiment of FIG. 17 illustrates that thefill apparatus 210 (refer to FIG. 16) is able to be disconnected fromthe piston body 74. In various embodiments, the system 200 includes thepiston septum 76, and the piston septum 76 is self-sealing such that thepiston septum 76 is able to seal after being pierced so as to keep aninfusion medium within the reservoir 40 when the piston septum 76 is notbeing pierced. In various embodiments, the plunger shaft 60 includes theplunger shaft engagement portion 64 that is able to be engaged with thepiston body engagement portion 75 so as to connect the plunger shaft 60to the piston body 74.

FIG. 18 illustrates the portion of an embodiment of the system 200 inaccordance with the embodiment illustrated in FIG. 17. As is illustratedin FIG. 18, in various embodiments, the piston body 74 includes a pistonbody engagement portion 75 and the plunger shaft 60 includes a plungershaft engagement portion 64 that is able to be engaged with the pistonbody engagement portion 64. Also, in such embodiments, when the plungershaft engagement portion 64 of the plunger shaft 60 is engaged with thepiston body engagement portion 75 of the piston body 74, at least aportion of the plunger shaft mating portion 62 of the plunger shaft 60may be exposed outside of the reservoir 40 so as to allow for matingwith the drive device linkage portion 82 of the drive device 80 (referto FIGS. 8 and 9).

FIG. 19 illustrates a flow chart of a method of using an embodiment ofthe system 200 in accordance with an embodiment of the presentinvention. In describing the embodiment of the method illustrated by theflow chart in FIG. 19, reference will be made to various elements ofembodiments of the system 200 illustrated in FIGS. 15-18. In S30, thepiston septum 76 is pierced with the transfer element 212 of the fillapparatus 210. In various embodiments, the step S30 includes a step S31of engaging the fill apparatus engagement portion 211 with the pistonbody engagement portion 75. Also, in various embodiments, the step S30further includes a step S32 of compressing the compressible portion 213of the fill apparatus 210 so as to cause the transfer element 212 topierce the piston septum 76. The method then continues to S33.

In S33, an infusion medium is transferred from an infusion mediumcontainer to the reservoir 40 through an opening in the piston body 74.In some embodiments, the step S33 includes a step S34 of pulling thefill apparatus 210 so as to move the piston 70 within the reservoir 40to allow the infusion medium to fill or flow into the reservoir 40 fromthe infusion medium container through the opening in the piston body 74.The method then continues to S35.

In S35, the fill apparatus engagement portion 211 of the fill apparatus210 is disengaged from the piston body engagement portion 75, and themethod continues to S36. In S36, the plunger shaft engagement portion 64is engaged with the piston body engagement portion 75, and the methodcontinues to S37. In S37, the port 41 of the reservoir 40 is connectedto the infusion path 50 that allows for a transfer of the infusionmedium from the reservoir 40 to the body of a user. The method thencontinues to S38.

In S38, the drive device linkage portion 82 of the drive device 80 ismated with the plunger shaft mating portion 62 of the plunger shaft 60,and the process continues to S39. In S39, the motor 84 is controlled tomove the drive device linkage portion 82 of the drive device 80 to movethe plunger shaft 60 so as to move the piston 70 to force the infusionmedium out of the reservoir 40 and deliver the infusion medium to thebody of the user. The method then ends at S40.

FIG. 20 illustrates a block diagram of a system 300 in accordance withan embodiment of the present invention. In various embodiments, thesystem 300 includes a reservoir filling system that allows for filling areservoir, or the like. Also, in various embodiments, the system 300includes a delivery device, such as the delivery device 12 (refer toFIGS. 2 and 3), or the like. In some embodiments, the system 300includes an infusion medium delivery system, such as the infusion mediumdelivery system 10 (refer to FIG. 1), or the like. In variousembodiments, the system 300 includes the reservoir 40, an infusionmedium container 310, a plunger 320, and a transfer guard 330. Also, invarious embodiments, the system 300 further includes the piston 70, theplunger shaft 60, the infusion path 50, the drive device 80, theelectronic circuitry 17, the disposable housing 20, and the durablehousing 30.

The infusion medium container 310 allows for holding an infusion medium.In various embodiments, the infusion medium container 310 includes avial, a canister, or the like. The plunger 320 is disposed at leastpartially within the infusion medium container 310, and the plunger 320is moveable within the infusion medium container 310. The plunger 320includes a plunger body 322 and a plunger septum 324. The plunger body322 is configured to allow for forcing the infusion medium out of theinfusion medium container 310, and the plunger body 322 is configured tohave an opening.

The plunger septum 324 is capable of being pierced to allow the infusionmedium to flow out of the infusion medium container 310 through theopening in the plunger body 322. The plunger body 322 may be made of asuitably rigid material such as, but not limited to, metal, plastic,ceramic, glass, a composite material, or the like. The plunger septum324 may be formed of a suitable material such as, but not limited to,rubber, silicone rubber, polyurethane, or other materials that may bepierced by a needle and form a seal around the needle. In variousembodiments, the plunger septum 324 includes a self-sealing septum.

The transfer guard 330 includes a transfer element 332 for piercing theplunger septum 324 and for providing a path to allow the infusion mediumto be transferred from the infusion medium container 310 to thereservoir 40. In various embodiments, the transfer element 332 includesa needle or the like. In some embodiments, the transfer guard 330further includes a first guard portion 334 and a second guard portion336. The first guard portion 334 is capable of at least partiallysurrounding a first end of the transfer element 332. The second guardportion 336 is capable of at least partially surrounding a second end ofthe transfer element 332. In various embodiments, the first guardportion 334 and the second guard portion 336 include one or more ofmetal, plastic, rubber, glass, composite material, or the like.

FIG. 21 illustrates a portion of an embodiment of the system 300 inaccordance with an embodiment of the present invention. As isillustrated in FIG. 21, the infusion medium container 310 allows forholding an infusion medium, and the plunger 320 is disposed within theinfusion medium container 310. The plunger 320 has the plunger body 322with an opening, and the plunger septum 324 is located within theopening in the plunger body 322. In various embodiments, the plunger 320has a diameter that is substantially the same as an inner diameter ofthe infusion medium container 310. Also, in various embodiments, theplunger 320 includes one or more seals 323, such as o-rings, forcreating a seal between the plunger 320 and an inner surface of theinfusion medium container 310. The plunger 320 is moveable within theinfusion medium container 310.

In the embodiment of the system 300 illustrated in FIG. 21, the plungerseptum 324 is capable of being pierced by one end of the transferelement 332 of the transfer guard 330. Also, another end of the transferelement 332 of the transfer guard 330 is able to pierce the septum 43located in the port 41 of the reservoir 40. As a consequence, thetransfer element 332 is able to provide a transfer path for transferringan infusion medium from the infusion medium container 310 to thereservoir 40. As is illustrated in FIG. 21, in various embodiments, thefirst guard portion 334 of the transfer guard 330 is able to be engagedwith the plunger 320.

Also, in various embodiments, the first guard portion 334 includes acompressible portion, such as a bellows or the like, that expands tocover an end of the transfer element 332 when the transfer guard 330 isnot engaged with the plunger 320, and that compresses to allow the endof the transfer element 332 to be exposed when the transfer guard 330 isengaged with the plunger 320. In some embodiments, the second guardportion 336 at least partially surrounds another end of the transferelement 332. Thus, in various embodiments, the transfer element 332includes a needle and the transfer guard 330 is able to prevent theneedle from being accessible unless the transfer guard 330 is engagedwith the plunger 320 or the reservoir 40, so as to prevent injury to auser due to handling of the transfer guard 330.

In some embodiments, when the first guard portion 334 of the transferguard 330 is mated with the plunger 320 and the second guard portion 336of the transfer guard 330 is mated with the reservoir 40 such that thetransfer element 332 provides the transfer path from the infusion mediumcontainer 310 to the reservoir 40, the plunger 320 is able to beadvanced within the infusion medium container 310 so as to force aninfusion medium from the infusion medium container 310 to the reservoir40. In various embodiments, the plunger 320 is advanced within theinfusion medium container 310 by, for example, a user pushing down onthe infusion medium container 310. In some embodiments, the piston 70with the attached or connected plunger shaft 60 is configured to bepushed back within the reservoir 40 as the infusion medium fills intothe reservoir 40 through the port 41.

In various embodiments, the piston 70 includes the piston degassingportion 72 to allow for gases to be released from the reservoir 40 oncethe reservoir 40 has been filled with an infusion medium. In variousembodiments, the piston degassing portion 72 includes a hydrophobicmaterial that will allow air and other gases to pass through, but willsubstantially prevent the passage of an infusion medium, such as aliquid, syringe deliverable insulin, or the like. Examples of structuresthat permit air-flow, but that inhibit fluids can be found in U.S.patent application Ser. No. 10/328,393 filed Dec. 22, 2003, and entitled“Reservoir Connector,” and U.S. patent application Ser. No. 10/699,429filed Oct. 31, 2003, and entitled “External Infusion Device with aVented Housing,” both of which are incorporated herein by reference intheir entirety. In some embodiments, the system 300 includes theinfusion path 50 and the infusion path 50 further includes a degassingportion (not shown in FIG. 21) for allowing gas to escape from theinfusion path 50 while keeping the infusion medium within the infusionpath 50.

In various embodiments that include the piston degassing portion 72,once gases are removed from the reservoir 40 through the pistondegassing portion 72, the piston 70 is sealed to prevent gases fromre-entering the reservoir 40 and to prevent evaporation of an infusionmedium in the reservoir 40. In some embodiments that include the pistondegassing portion 72, the piston degassing portion 72 is used to degasthe reservoir 40 with positive pressure and then is removed or coveredto prevent evaporation of an infusion medium that is in the reservoir40.

In various embodiments, the system 300 includes the infusion path 50and, once the reservoir 40 has been filled, the transfer guard 330 isremoved or disconnected from the port 41 of the reservoir 40 and theinfusion path 50 is connected to the port 41 of the reservoir 40. Thus,in various embodiments of the system 300, the reservoir 40 is able to befilled with an infusion medium from a same port that is used fordelivering the infusion medium to the body of a user. In various otherembodiments, the reservoir 40 includes a second port that is differentfrom the port 41, and the second port is connected to the infusion path50, such that the reservoir 40 is able to be filled with an infusionmedium through a different port than a port that is used for deliveringthe infusion medium to the body of a user.

FIG. 22 illustrates a flow chart of a method of using an embodiment ofthe system 300 in accordance with an embodiment of the presentinvention. In describing the embodiment of the method illustrated by theflow chart in FIG. 22, reference will be made to various elements ofembodiments of the system 300 illustrated in FIGS. 20-21. In S50, thetransfer guard 330 is connected to the reservoir 40, and the methodcontinues to S51. In S51, the plunger septum 324 of the plunger 320 ispierced with the transfer element 332 of the transfer guard 330, and themethod continues to S52.

In S52, the infusion medium container 310 is moved so as to cause aninfusion medium to be transferred from the infusion medium container 310to the reservoir 40 through the opening in the plunger body 322. Invarious embodiments, the step S52 includes a step S53 of moving theinfusion medium container 310 to cause the plunger body 322 to advancewithin the infusion medium container 310 so as to force the infusionmedium out of the infusion medium container 310 through the opening inthe plunger body 322. The method then continues to S54.

In S54, the transfer guard 330 is disconnected from the reservoir 40,and the method continues to S55. In S55, the reservoir 40 is connectedto the infusion path 50 that allows for a transfer of the infusionmedium from the reservoir 40 to the body of a user, and the methodcontinues to S56. In S56, the drive device linkage portion 82 of thedrive device 80 is mated with the plunger shaft mating portion 62 of theplunger shaft 60, and the method continues to S57. In S57, the motor 84is controlled to move the drive device linkage portion 82 of the drivedevice 80 to move the plunger shaft 60 so as to move the piston 70 toforce the infusion medium out of the reservoir 40 and into the body ofthe user. The method then ends at S58.

FIG. 23 illustrates a block diagram of a system 400 in accordance withan embodiment of the present invention. In various embodiments, thesystem 400 includes a reservoir filling system that allows for filling areservoir, or the like. Also, in various embodiments, the system 400includes a delivery device or the like. In some embodiments, the system400 includes an infusion medium delivery system, such as the infusionmedium delivery system 10 (refer to FIG. 1), or the like.

The system 400 includes a reservoir 440 for receiving an infusion mediumfrom an infusion medium container 410. The reservoir 440 includes acollapsible housing 443 having an interior volume for holding theinfusion medium, where the collapsible housing 443 is collapsible froman expanded state to reduce the interior volume and is expandable from acollapsed state to increase the interior volume, and the collapsiblehousing 443 is biased toward the expanded state. In various embodiments,the collapsible housing 443 includes a bellows or the like. Also, invarious embodiments, the collapsible housing 443 includes metal, rubber,plastic, or the like. In some embodiments, the collapsible housing 443includes at least one of titanium, stainless steel, or the like.

The collapsible housing 443 is configured such that upon the collapsiblehousing being expanded toward the expanded state, a pressuredifferential is created between the interior volume of the collapsiblehousing and the infusion medium container 410 sufficient to transfer theinfusion medium from the infusion medium container 410 to the interiorvolume of the collapsible housing 443. In various embodiments, thecollapsible housing 443 further includes a bias member 444 for biasingthe collapsible housing 443 toward the expanded state. In variousembodiments, the bias member 444 includes a spring, such as a coilspring, or the like. In some embodiments, the collapsible housing 443may be configured as a structure that has its own spring force forbiasing the collapsible housing 443 toward the expanded state.

In various embodiments, the system 400 further includes a lever 420. Thelever 420 is moveable between a plurality of positions including a firstposition and a second position. The lever 420 is able to keep thecollapsible housing 443 in the collapsed state when the collapsiblehousing 443 is in the collapsed state and the lever 420 is in the firstposition. In various embodiments, the collapsible housing 443 is able toexpand to the expanded state when the lever 420 is in the secondposition. In some embodiments, the lever 420 is made of, for example,metal, plastic, rubber, glass, composite material, or the like. In someembodiments, the lever 420 is moveable among multiple positions along anexpansion direction of the collapsible housing 443.

In various embodiments, the system 400 further includes a pump 430, suchas a peristaltic pump or the like, for transferring an infusion mediumfrom the collapsible housing 443 to the body of a user when the port 441of the reservoir 440 is connected to the infusion path 50. In variousembodiments, the pump 430 is a peristaltic pump or other pump that usesnegative pressure to draw the infusion medium from the collapsiblehousing 443 and that is able to supply the infusion medium to the bodyof the user. In some embodiments, the system 400 further includes thedisposable housing 20, the durable housing 30, and the electroniccircuitry. In various embodiments, the disposable housing 20 includesthe base 21 and the reservoir 440 is supported by the base 21. In someembodiments, the pump 430 is housed in the durable housing 30. Also, insome embodiments, the system 400 includes a screw driven slide (notshown) for causing an infusion medium to be transferred from thecollapsible housing 443 to the body of a user when the port 441 of thereservoir 440 is connected to the infusion path 50.

FIG. 24 illustrates an embodiment of the system 400. In variousembodiments, a formed metal bellows or the like is used as thecollapsible housing 443. In some embodiments, the collapsible housing443 includes a bellows and the bellows is configured with a built-inspring force that biases the bellows toward an expanded state. In FIG.24, the collapsible housing 443 is illustrated as being in a collapsedstate. In various embodiments, during assembly of the system 400, avacuum device is applied to an interior of the bellows through a septum447, such as a silicone septum or the like, in the port 441 so as tocause the collapsible housing 443 to collapse to the collapsed state.

FIG. 25 illustrates an embodiment of the system 400. As is illustratedin FIG. 25, in various embodiments the collapsible housing is able to bekept in a collapsed state by the lever 420 when the lever is in a firstposition. In the embodiment illustrated in FIG. 25, the lever 420 is inthe first position and the collapsible housing is held in the collapsedstate by the lever 420. In various embodiments, an inherent spring forceof the collapsible housing 440 biases the collapsible housing toward theexpanded state. In various other embodiments, the bias member 444 (referto FIGS. 23 and 24) biases the collapsible housing toward the expandedstate. In some embodiments, the reservoir 440 is located at leastpartially within the disposable housing 20.

FIG. 26 illustrates an embodiment of the system 400. In the embodimentillustrated in FIG. 26, the system 400 further includes the infusionmedium container 410, such as a vial, a canister, or the like, thatallows for holding an infusion medium. As is illustrated in FIG. 26, atransfer element 450, such as a needle or the like, may be used topierce the septum 447 of the reservoir 440 and to provide a transferpath for an infusion medium from the infusion medium container 410 to aninterior volume 445 of the collapsible housing 443.

Also, in FIG. 26, the lever 420 is illustrated as being in the secondposition, such that the collapsible housing has been allowed to expandto the expanded state. In various embodiments, upon moving the lever 420from the first position to the second position, the collapsible housing443 expands toward the expanded state due to the bias of the collapsiblehousing, and a pressure differential is created between the interiorvolume 445 of the collapsible housing 443 and the infusion mediumcontainer 410 sufficient to transfer the infusion medium from theinfusion medium container to the interior volume 445 of the collapsiblehousing 443. In various embodiments, the lever 420 is moveable among aplurality of positions. For example, in some embodiments, the lever 420is movable among a plurality of positions along an expansion directionof the collapsible housing 443. Also, in various embodiments, the lever420 is rotatable among a plurality of positions. In some embodiments,the lever 420 is moveable among a plurality of positions such that eachposition for the lever 420 allows for a different amount of expansion ofthe collapsible housing 443.

In various embodiments of the system 400, once the interior volume 445of the collapsible housing 443 has been filled with an infusion medium,the transfer element 450 may be disconnected from the port 441 of thereservoir 440, and the port 441 of the reservoir 440 may be connected tothe infusion path 50 to allow for transferring the infusion medium fromthe reservoir 440 to the body of a user. In some embodiments, thecollapsible housing 443 is able to be pushed so as to collapse thecollapsible housing 443 and force the infusion medium out of thecollapsible housing 443. In some embodiments, the pump 430 is providedto draw the infusion medium out of the collapsible housing 443 throughthe port 441.

FIG. 27 illustrates a block diagram of a system 500 in accordance withan embodiment of the present invention. In various embodiments, thesystem 500 includes a reservoir filling system that allows for filling areservoir, or the like. Also, in various embodiments, the system 500includes a delivery device or the like. In some embodiments, the system500 includes an infusion medium delivery system, such as the infusionmedium delivery system 10 (refer to FIG. 1), or the like.

The system 500 includes a reservoir 510 for receiving an infusion mediumfrom the infusion medium container 410. The infusion medium containerhas an interior volume for holding the infusion medium. The reservoir510 includes a collapsible housing 512 and a chamber housing 514. Thecollapsible housing 512 has an interior volume for holding the infusionmedium, where the collapsible housing 512 is collapsible from anexpanded state to reduce the interior volume of the collapsible housing512 and is expandable from a collapsed state to increase the interiorvolume of the collapsible housing 512. The chamber housing 514 has aninterior volume bordered on at least one side by the collapsible housing512 such that the interior volume of the chamber housing 514 increasesas the collapsible housing 512 collapses toward the collapsed state andsuch that the interior volume of the chamber housing 514 decreases asthe collapsible housing 512 expands toward the expanded state.

The collapsible housing 512 and the chamber housing 514 are configuredsuch that when (i) a gaseous pressure within the interior volume of thechamber housing 514 is less than a particular gaseous pressure withinthe interior volume of the infusion medium container 410 and (ii) thecollapsible housing 512 is in the collapsed state and (iii) a path fortransferring the infusion medium is established between the interiorvolume of the infusion medium container 410 and the interior volume ofthe collapsible housing 512, the collapsible housing 512 and the chamberhousing 514 allow for a pressure differential between the interiorvolume of the chamber housing 514 and the interior volume of theinfusion medium container 410 to cause the collapsible housing 512 toexpand and to cause the infusion medium to be pushed from the infusionmedium container 410 to the collapsible housing 512.

In various embodiments, the collapsible housing includes a bellows orthe like. Also, in various embodiments, the collapsible housing includesplastic or the like. In some embodiments, the collapsible housingincludes one or more of metal, plastic, rubber, composite material, orthe like. Also, in some embodiments, the system 500 further includes thedisposable housing 20 and the durable housing 30, and the reservoir 510is supported by the disposable housing 20. In some embodiments, thesystem 500 includes a screw driven slide (not shown) for causing aninfusion medium to be transferred from the collapsible housing 512 to abody of a user.

FIG. 28 illustrates an embodiment of the system 500. In FIG. 28, thecollapsible housing 512 is shown in the collapsed state. An interiorvolume 515 of the chamber housing 514 is defined within the chamberhousing 514, where the chamber housing is bordered on at least one sideby the collapsible housing 512. A port 516 of the reservoir 510 isprovided in various embodiments to allow for an infusion medium to flowinto the collapsible housing 512 and to flow out of the collapsiblehousing 512. Also, in various embodiments, a pierceable septum, such asa self-sealing septum or the like, is provided within the port 516 toblock the port 516 when the septum 517 is not pierced.

FIG. 29 illustrates an embodiment of the system 500. In FIG. 29, thecollapsible housing 512 is shown in the expanded state. The interiorvolume 515 of the chamber housing 514 is reduced when the collapsiblehousing 512 expands from the collapsed state to the expanded state.Also, an interior volume 518 of the collapsible housing 512 increases asthe collapsible housing 512 expands from the collapsed state to theexpanded state. In the embodiment illustrated in FIG. 29, the system 500further includes the infusion medium container 410 having an interiorvolume 419 for holding an infusion medium. In some embodiments, thesystem 500 further includes a transfer element 530, such as a needle orthe like, that is able to pierce the septum 517 located within the port516 of the reservoir 510.

In various embodiments, during assembly of the system 500, a vacuum isapplied to the interior volume 515 of the chamber housing 514, causingthe collapsible housing 512 to expand toward the expanded state. In someembodiments, the chamber housing 514 may be hermetically sealed. Then,during an assembly process in accordance with an embodiment of thepresent invention, a vacuum may be applied to the interior volume 518 ofthe collapsible housing 512 through the septum 517 to cause thecollapsible housing 512 to collapse to the collapsed state.

After the system 500 has been assembled, in various embodiments, thecollapsible housing 512 is able to be filled with an infusion medium byattaching the infusion medium container 410 to the transfer element 530and then piercing the septum 517 of the reservoir 510 with the transferelement 530. Then, in some embodiments, a differential pressure betweenthe vacuum of the interior volume 515 of the chamber housing 514 and thegaseous pressure of the interior volume 419 of the infusion mediumcontainer 410 causes the infusion medium to be transferred from theinfusion medium container 410 to the reservoir 510.

In various embodiments, the port 516 of the reservoir 510 may beconnected to the infusion path 50 to allow for delivering an infusionmedium from the reservoir 510 to the body of a user. In someembodiments, the system 500 further includes the pump 430, such as aperistaltic pump or the like, for drawing the infusion medium out of thereservoir 510 and for delivering the infusion medium to the body of theuser through the infusion path 50. In various embodiments, the system500 further includes the electronic circuitry 17 for controlling thepump 430. Also, in various embodiments, system 500 includes thedisposable housing 20, the durable housing 30, the reservoir 510, andthe pump 430, where the reservoir 510 is supported by the disposablehousing 20, and the pump 430 is housed in the durable housing 30. Insome embodiments, the disposable housing 20 and the durable housing 30may both be connected to a base element (not shown) that is then securedto a body of a user.

The embodiments disclosed herein are to be considered in all respects asillustrative, and not restrictive of the invention. The presentinvention is in no way limited to the embodiments described above.Various modifications and changes may be made to the embodiments withoutdeparting from the spirit and scope of the invention. The scope of theinvention is indicated by the attached claims, rather than theembodiments. Various modifications and changes that come within themeaning and range of equivalency of the claims are intended to be withinthe scope of the invention.

1. A system, comprising: a reservoir for receiving an infusion mediumfrom an infusion medium container, the infusion medium container havingan interior volume for holding the infusion medium, the reservoircomprising: a collapsible housing having an interior volume for holdingthe infusion medium, the collapsible housing being collapsible from anexpanded state to reduce the interior volume of the collapsible housingand being expandable from a collapsed state to increase the interiorvolume of the collapsible housing; and a chamber housing having aninterior volume bordered on at least one side by the collapsible housingsuch that the interior volume of the chamber housing increases as thecollapsible housing collapses toward the collapsed state and such thatthe interior volume of the chamber housing decreases as the collapsiblehousing expands toward the expanded state; wherein the collapsiblehousing and the chamber housing are configured such that when (i) agaseous pressure within the interior volume of the chamber housing isless than a particular gaseous pressure within the interior volume ofthe infusion medium container and (ii) the collapsible housing is in thecollapsed state and (iii) a path for transferring the infusion medium isestablished between the interior volume of the infusion medium containerand the interior volume of the collapsible housing, the collapsiblehousing and the chamber housing allow for a pressure differentialbetween the interior volume of the chamber housing and the interiorvolume of the infusion medium container to cause the collapsible housingto expand and to cause the infusion medium to be pushed from theinfusion medium container to the collapsible housing.
 2. The system ofclaim 1, wherein the collapsible housing comprises a bellows.
 3. Thesystem of claim 1, wherein the collapsible housing comprises plastic. 4.The system of claim 1, wherein the collapsible housing comprises ametal.
 5. The system of claim 1, further comprising: a base adapted tobe secured to a user; a durable housing portion configured to beselectively engaged with and disengaged from the base; and electroniccircuitry contained in the durable housing portion; wherein thereservoir is supported by the base; and wherein the electronic circuitryis configured to control a delivery of the infusion medium from thereservoir to a body of the user when the durable housing portion and thebase are engaged.
 6. The system of claim 1, wherein the reservoirfurther comprises a port in fluid flow communication with the interiorvolume of the collapsible housing; and wherein the port is connectableto the infusion medium container.
 7. The system of claim 1, wherein thesystem is configured such that the infusion medium is able to betransferred from the collapsible housing to a body of a user.
 8. Thesystem of claim 1, further comprising: a base adapted to be secured tothe user; and a durable housing portion configured to be selectivelyengaged with and disengaged from the base; wherein the reservoir issupported by the base.
 9. A method of making a system, the methodcomprising: providing a chamber housing; providing a collapsible housinghaving an interior volume for holding an infusion medium, thecollapsible housing being collapsible from an expanded state to reducethe interior volume of the collapsible housing and being expandable froma collapsed state to increase the interior volume of the collapsiblehousing; connecting the collapsible housing to the chamber housing sothat an interior volume of the chamber housing is boarded on at leastone side by the collapsible housing and such that the interior volume ofthe chamber housing increases as the collapsible housing collapsestoward the collapsed state and the interior volume of the chamberhousing decreases as the collapsible housing expands toward the expandedstate; reducing a gaseous pressure within the interior volume of thechamber housing; and reducing a particular gaseous pressure within theinterior volume of the collapsible housing after the gaseous pressurewithin the interior volume of the chamber housing has been reduced. 10.A method for using a system, the system comprising a reservoir forreceiving an infusion medium from an infusion medium container, theinfusion medium container having an interior volume for holding theinfusion medium, the reservoir comprising a collapsible housing havingan interior volume for holding the infusion medium, the collapsiblehousing being collapsible from an expanded state to reduce the interiorvolume of the collapsible housing and being expandable from a collapsedstate to increase the interior volume of the collapsible housing, thereservoir further comprising a chamber housing having an interior volumebordered on at least one side by the collapsible housing such that theinterior volume of the chamber housing increases as the collapsiblehousing collapses toward the collapsed state and such that the interiorvolume of the chamber housing decreases as the collapsible housingexpands toward the expanded state, the method comprising: establishing apath for transferring the infusion medium between the interior volume ofthe infusion medium container and the interior volume of the collapsiblehousing when (i) a gaseous pressure within the interior volume of thechamber housing is less than a particular gaseous pressure within theinterior volume of the infusion medium container and (ii) thecollapsible housing is in the collapsed state, such that a pressuredifferential between the interior volume of the chamber housing and theinterior volume of the infusion medium container causes the collapsiblehousing to expand and to cause the infusion medium to be pushed from theinfusion medium container to the collapsible housing.